TRUCKS

Choosing a truck is a very complex matter, which must always be discussed with your technical department.

A digital guide to help with the decision to "procure or rent" is available and allows, by going through different steps, to:

• process an analysis of your needs and the ability of your mission to manage and maintain a truck.
• decide between "procurement" or "rent" and in case of a choice to procure, between local procurement or international procurement (decision HQ).
• communicate between the field and head quarters about this topic
• capitalise on the analysis.

The digital guide is called "Truck Rent or Buy Analysis" and is available under the MSF tools and reference books in the digital catalogue and on SherLog.

Evaluation of needs, some guidance:

Begin by assessing your needs, answering the questions below as fully as possible, before considering possible solutions.

• When will the need for a truck begin?
• For how long?
• How many days per week?
• How many kilometres per week?
• For what kind of goods?
• What is the approximate payload needed?
• What is the approximate volume needed?
• How is the quality of the roads?
• What do other organizations do about transport?
• What is the fleet of trucks available locally regarding quantity, models, owners?
• Is it possible to use a local haulage contractor?
• Is it possible to rent a truck locally?
• Is it possible to share the transport capacity of other organisations?
• What type of truck do you need: a 4x2 or 4x4?
• Is it possible to buy a new or second-hand truck locally or regionally?
• What is the local availability of spare parts, and for which brands?
• Is it possible to recruit locally a good truck driver, a good driver's mate, and a good mechanic?
• Is there a good mechanical workshop in the area for repairs?
• Do you have the resources in terms of HR and materials to manage and maintain a truck?

The final decision should be taken between the operational section (mission and HQ) and the technical department.

An MSF truck allows for some flexibility and self-reliance in operations, while its management needs technical and HR means that should not be overlooked.

Contact your technical department to make the evaluation tool "procure or rent" available, for further discussions.

The procurement of a vehicle, either new or second-hand should always be discussed with your technical department and approved by them.

Possible solutions

• Contract with a local haulage firm

This is usually the best solution.

• Advantage: the haulage firm is responsible for the truck and for any problems occurring during transportation
• Disadvantage: less flexibility

A contract should be drawn up for each journey. This contract should clearly specify who is responsible for what with regards to loading and transportation.

For transport of sensitive or costly goods, or if there is a risk of theft, have an MSF staff member ride in the truck.

• Renting a truck locally

• Advantage: more flexibility
• Disadvantage: more work and more responsibilities for MSF

One contract should be adequate for all the journeys during the rental period.

This contract should clearly specify who is responsible for what with regards to the truck, its loading and the transportation.

Try to get the owner to assume responsibility for maintenance.

It is always preferable to rent a truck with a driver: although more expensive, this considerably reduces MSF's liability.

• Purchasing a truck

To be considered only as a last resort.

• advantage: more flexibility and independence
• disadvantages: significant investment, which will pay for itself only in the long term, and even then only if well managed (planning, maintenance, repairs, spare parts etc.)

It is essential to have a good and trustworthy truck driver, along with a driver's mate.

Of all the different possible options (new or second-hand truck, local or European purchase), buy a second-hand truck in Europe if you can. Avoid purchasing a second-hand truck locally.

Putting in place an adequate transport follow-up system is necessary to guarantee the security and operability of the material at a controlled cost.

The management of spare parts is quite complex.

In order to define the parts you need, you must first identify:

• the chassis type and number
• the engine type and number
• the year of assembly
• the front axle type and number
• the rear axle type and number
• the transfer box type and number (for 4x4)
• the gearbox type and number.

Finding part numbers in catalogues is a laborious task. However, if you give the suppliers the worn-out part and all the above information, they should be able to find the right part.

MANAGING THE VEHICLE FLEET

Vehicles are essential to the running of a project and must therefore be properly managed.

See the existing MSF guidelines on the subject.

Galenic formulations presented as co-formulations (a combination of several molecules in the same pharmaceutical form, know as "FDC" = fixed dose combination) are labelled with a "/" separating the different molecules.

Example: ATOVAQUONE 250mg / PROGUANIL HCl 100mg, tab., >40 kg

Galenical formulations presented as co-blisters (where molecules are in separate dosage forms but combined in the same blister pack) are labelled with a "+" symbol between the different molecules. The co-blister form is always mentioned in the label.

Example: SP 1 x 500/25mg + AQ 3 x eq.150-153mg base, coblister disp.tab, 9-17kg

Some excipients are prohibited in paediatric medicines, such as benzyl alcohol in injectable formulations and ethanol in oral formulations (unless no other source is available). Additionally, oral paediatric medicines containing sucrose should be avoided whenever possible in children.

Medicon reference

Almost all labels or surgical instruments give the Medicon reference at the end of the label. The reference has the following structure: 3 x 2 numbers separated by a dash e.g. 11-22-33.

The Medicon reference gives clear specifications for the article, but it remains an open article. Several sources (other than Medicon) are possible if the same quality level is met.

The reference of Medicon can also be used to view the article in their online catalogue (replace the dash by a dot to search in the Medicon catalogue).

Norms for surgical instruments

The technical commission 170 from ISO is responsible for the standardization in the field of surgical instruments

• ISO 7151:1988 (3rd edition is under development): Surgical instruments -- Non-cutting, articulated instruments -- General requirements and test methods
• specification of basic requirements for as well physical characteristics as workmanship, of the steel grades used and heat treatment of component parts, excluding rivets, screws and parts manufactured of material grade M.
• ISO 7153-1:2016: Surgical instruments -- Materials -- Part 1: Metals
• specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopaedics and dentistry.
• is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.
• ISO 7740:1985 (reviewed and confirmed in 2021): Instruments for surgery -- Scalpels with detachable blades -- Fitting dimensions
• lays down the dimensions of two sizes of fitting features for detachable scalpel blades and the handles with which they are used. It secures a good fitting and interchangeability of detachable blades for scalpels
• ISO 7741: 1986 (reviewed and confirmed in 2017): Instruments for surgery -- Scissors and shears -- General requirements and test methods
• deals with materials, heat treatment and hardness of component parts, corrosion resistance, workmanship and cutting ability of scissors and shears used in the surgery and defines the test methods.
• ISO 13402:1995 (reviewed and confirmed in 2021): Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure

Metals used to manufacture surgical instruments

Since there are different requirements to various surgical instruments, there also have to be different requirements to the materials from which the instruments are manufactured. Not all of the materials are suited to use in every type of instrument.

For most types of surgical instruments materials which are known from experience to be suitable for those instruments are given in the tables of ISO 7153.

Surgical stainless steel

Surgical stainless steel is a grade of stainless steel used in biomedical applications. There is no formal definition on what constitutes a "surgical stainless steel", product manufacturers and distributors apply the term to refer to any grade of corrosion resistant steel.Table 4 of ISO 7153 lists the grades of stainless steels used in surgical instruments using the material number and short term according to EN 10088-1:2014.

The most common "surgical steels" are austenitic 316 stainless steels and martensitic 440 and 420 stainless steels.

440 and 420 stainless steels, known also by the name "Cutlery Stainless Steel", are high carbon steels alloyed with chromium. They have very good corrosion resistance compared to other cutlery steels, but their corrosion resistance is inferior to 316 stainless. Biomedical cutting instruments are often made from 440 or 420 stainless steel due to its high hardness coupled with acceptable corrosion resistance. This type of stainless steel may be slightly magnetic.

316 stainless steel, also referred to as marine grade stainless steel, is a chromium, nickel, molybdenum alloy of steel that exhibits relatively good strength and corrosion resistance.

Chemical composition of the stainless steels

Stainless steel is a steel alloy with a minimum of 10.5% chromium content by mass and a maximum of 1.2% carbon by mass.

Alloy steel is steel that is alloyed with a variety of elements in total amounts between 1.0% and 50% by weight to improve its mechanical properties.

The simplest steels are iron (Fe) alloyed with carbon (C): about 0.1% to 1%, depending on type. As the carbon percentage content rises, steel has the ability to become harder and stronger through heat treating; however, it becomes less ductile. Regardless of the heat treatment, a higher carbon content reduces weldability.

The term "alloy steel" is the standard term referring to steels with other alloying elements added deliberately in addition to the carbon.

• Si = silicium: increases the hardness and wear resistance
• Mn = manganese: can increase the tensile strength, could remove or improve the bad influence of Sulfur, could improve the hardening capacity of heat treatment. High content of Mn will cause worse welding capability and reduce the heat conductivity of steel = easier to cause cracks.
• Ni = nickel: could improve the tensile strength and toughness of cast steel, improve the hardening capacity of heat treatment. High content of Ni could improve the corrosion resistance and the properties of other alloys.
• P = phosphorus: reduces the plasticity and toughness of cast steel, especially at low temperature: better to keep it at less than 0.04%.
• S = sulfur: is the harmful impurity of cast steel, it causes fragility, especially after quenching heat treatment, and during machining at high temperature. A lower Sulfur is better (less than 0.04%).
• Mo = molybdenum: could improve the hardening capacity, and heat-resisting strength of heat treatment, = reducing the brittleness of quenching treatment. It can also improve the surface abrasive resistance.
• V = vanadium: promotes fine grain size, increases hardenability and improves wear resistance. Small amount of Vanadium increases the strength of steels significantly

Surgical stainless steels for families of products

Pressure force instruments and springs (haemostatic forceps, dissecting forceps, gripping forceps, surgical towel clamps, needle holding forceps, threading forceps, clamping forceps) ► martensitic steel

• The steel used must be springy and highly impact resistant.
• Carbon gives them hardness, while chromium gives them corrosion resistance.
• The steel have to undergo a complex, rigorous heat treatment which allows the steel to be hardened; otherwise they will bend the first time they are used.
• The steel must be carefully polished; the quality of the polishing determines the corrosion resistance.

Instruments that cut by shearing (scissors curettes, raspatories, gouge shears, cutting forceps) ► martensitic steel

• The steel used has a higher percentage of carbon than for the pressure force instruments in order to increase hardness.
• The percentage of chromium is the same to give corrosion resistance, while incorporation of molybdenum makes up the balance and improves the cutting qualities.

Instruments that cut by percussion (chisel shears, osteotomes, gouges) ⇒ martensitic steel

• For the cutting part, the heat treatment and polishing are the same as for instruments that cut by shearing.
• For the non cutting part, the heat treatment and polishing are the same as for pressure force instruments.

Static function instruments: self-retaining retractors, long-handles retractors, valves, specula, dilators) ► martensitic or austenitic steel

Miscellaneous instruments (instrument boxes, obstetrical hook, manual drill) ► austenitic steel

Hard metals used in surgical instruments

Alloy type used for instruments with wear protection (inserts or coating):

• cobalt-chrome-tungsten: for scissors
• tungsten carbide cobalt-binder: for forceps and needle holders
• tungsten carbide nickel-binder: for forceps, scissors and needle holders

Tungsten carbide is a chemical compound containing equal parts of tungsten and carbon atoms. It is approximately twice as stiff as steel and is double the density of steel—nearly midway between that of lead and gold.

Tungsten Carbide materials have a unique combination of properties, high compressive strength, hardness and resistance to wear, as well as an ability to withstand shock and impact.

The binder in most grades of Tungsten Carbide is cobalt. The other binder used is nickel. The binder is added as a percentage by weight varying from 3% to 30%. The amount of binder used is a very important factor in determining the properties of each grade. As a rule of thumb the lower the cobalt content the harder the material will become. However variation in grain size and additives can upset this rule.

Titanium used in surgical instruments

Different grades of pure titanium and titanium alloy are used in surgical instruments. Information about the quality can be found in ISO 5832 Implants for surgery -- Metallic materials

Retractors and probes: pure titanium = Unalloyed Commercially Pure (CP) Titanium, ISO implant quality 5832-2 grade 1, 2, 3 and 4. Grade 1 has the highest corrosion resistance, formability and lowest strength, grade 4 offers the highest strength and moderate formability.

A titanium alloy (ISO 5832-3) can be used for: forceps, scissors, retractors, probes, needle holders, springs, screws, rivets, guide pins.

Titanium is naturally a grey metal, but by anodizing the surgical instruments, manufacturers change the surface properties of the metal. Titanium surgical instruments are typically blue. The anodizing also makes the surgical instruments non-reflective so that there is no glare.

Titanium surgical instruments offer several advantages over stainless steel instruments:

• lightweight: reduces hand fatigue especially during long surgical procedures
• high tensile strength.
• durable, even after repeated autoclaving without damaging the surfaces or cutting edges
• corrosion resistant, non-ferrous (it will not rust), non-magnetic (=MRI compatible) and bio-compatible.

The MSF set of documents that include guidelines and catalogues embody the collective experiences of medical and logistics technicians from all MSF sections, whose years of experience have been compiled with the aim of helping the field staff in their daily work, speed up our interventions, and standardize our practices.

1. GUIDELINES

The guidelines concerning methods and protocols for implementation were the first documents to be produced. They indicate the most effective way to face up to a problem in a limited resources environment. As their use is not exclusively reserved for MSF, they propose a wider selection than what is actually available in the field (e.g.: the MSF guidelines “essential drugs” mentions some products which are not used by MSF, but which are still used in some countries).

2. CATALOGUES (9 VOLUMES)

The catalogues are common to all MSF sections. They propose medical and non-medical products selected by the MSF referents as being the most suitable for a given situation. They are used as reference and technical support for missions and supply centres, as well as specifications for technicians, purchasers and persons in charge of articles’ quality control at reception.

• The LOGISTICS (1 volume) and MEDICAL (7 volumes) CATALOGUES constitute THE REFERENCE regarding the selection, the use, the maintenance and the storage of standard articles which are used in MSF missions.
• The KITS CATALOGUE (1 volume) allows for the planning and quantifying of emergency operations due to a description of the type of use and the detailed content of each kit.

Catalogues are updated during international working/contact group meetings and their content is validated by the medical directors of the five operational centres of MSF. They are bilingual (English/French)

The catalogues can be ordered together (as a set of 7 catalogues) or separately through your OC library focal point (Bibop).

3. PUBLISHING OF MSF DOCUMENTS

The international MSF guidelines are available through the international medical guidelines website
https://medicalguidelines.msf.org/viewport/MG/en/guidelines-16681097.html

Some international MSF guidelines are for internal use and only available for the MSF world. They are posted on the Sharepoint.https://msfintl.sharepoint.com/sites/msfintlcommunities/IGP

The catalogues are edited by SPINCO once a year. They are simultaneously published on paper, electronic format (memory key) and posted on the Intranet (Sharepoint), from the international masterdata platform, UniData, managed by SPINCO.https://msfintl.sharepoint.com/sites/msfintlcommunities/MSFCatalogues

Since 2021, the new platform UniCat is accessible on the web. It also enables to see the articles with their technical sheet/FFF. The advantages of UniCat are the daily updates and the ease of use.
https://unicat.msf.org/

The technical sheets, the Form Fit & Function (FFF) specifications and the photos of articles can also be viewed in UniData at any time.

The electronic version on Sharepoint also includes:

• the international MSF guidelines which are linked to the medical or logistic catalogues
• “Clinical guidelines”
• “Essential drugs”
• “Essential obstetric and newborn care”
• “Management of a cholera epidemic”
• “Management of a measles epidemic”
• “Tuberculosis”
• “Public health engineering in precarious situations”
• “Refugee health”
• “Temporary Health Structures”
• “Blood transfusion”
• “Management of epidemic meningococcal meningitis”
• “Rapid health assessment of refugee or displaced populations”
• “Integrating HIV & TB care in basic health care package in MSF projects”
• “Paediatric HIV Handbook”
• “Neonatal care. Clinical and therapeutic guidelines”
• "Mental Helath and Psychosocial Support Guideline"
• “Laboratory manual”
• "MSF laboratory quality assurance manual"
• "Collection, storage and transport of samples"
• “Electrical Installations and Equipment in the Field”
• “Ultrasound manual. For trained practioners”
• “X-ray manual. Guidelines for implementation and provision of x-ray services”
• the MSF TOOLS: pictures of the surgical sets, medical, food and logistical stationary forms, Excel file with kit contents, summary of changes and some logistical guides

4. FEEDBACK FROM THE FIELD

The MSF documents evolve for the most part thanks to continuous FEEDBACK from the field and from other users. Don’t hesitate to contact SPINCO (spinco.medical@msf.org or spinco.logistics@msf.org) to tell us about your experience !

The Delivery part of the hospital kit is a complementary part to the ward.

• Material to perform about 50 deliveries
• Material for the care of 5 neonates
• All furniture is optional (delivery table, examination table, Mayo table, stretcher, stool, infant warmer)

It is composed of two main parts:

• Medical equipment
• Medicines and renewable medical supplies

A protocol for starting an orthopaedic programme with internal fixation exists for the MSF missions.

The authorization to practise internal fixations in an MSF mission must meet all the criteria listed in the reference document. They are absolute minimum criteria checked and signed by a referent before implementing such a programme.

The articles can only be used in projects where the prerequisites for internal fixation are already in place and internal fixation is ongoing with good follow up of surgical complications and surgical infections.

Only orthopedic surgeons are allowed to use these sets.

For information follows a non-exhaustive and non-detailed list about the means which must be present.

Material means

• Operation suite: electricity, air, water, electric cautery, tourniquet, single use gowns, surgical gloves, alcohol hand rub, iodineskin preparations...
• Sterilization: existing sterilization circuit (clean/dirty), autoclave with cycle at 134°C, MSF protocols for sterilization, tracability and sterilization indicators ...
• Radiology: must be present...
• Laboratory: blood transfusion, bacteriology examinations...
• In Patient Department: clear separation infected and not...

Human Resources

• OT nurse
• Ward nurse
• Surgeons: qualified "MSF" orthopedics
• Physiotherapist
• Prothesist
• Anesthetist...

Protocols

• Antibiotics
• Thromboembolic prevention
• Pain

Data collection

• Data collection according existing forms

Organization

• Implementing evaluation systems in the different parts: sterilization, data collection, complications, anesthaesia quality, mortality...

All articles for internal fixation are closed: manufacturer is STRYKER or SIGN.

Codification of the articles: manufacturer (STRY or SIGN) followed by the reference of the manufacturer.

The content of these lists may change for several reasons. MSF is always looking for the best products in terms of quality/price ratio and the manufacturer can also update his product list.

A laboratory should be adapted to the specific needs of a project. As there are many different set-ups and activities there is no standard kit for a complete laboratory.

Select and combine standard laboratory modules to start laboratory activities according to the projects needs.

Modules generally can contain different types of items;

• equipment or investment material, to be ordered once
• renewable supplies for sample collection and transport and carrying out the tests
• specific reagents for each test

When ordering the modules initially, make sure all 3 components are selected (equipment + renewable supplies + reagents). Afterwards items can be separately ordered according to the actual consumption.

There are different types of laboratory modules:

• sample collection and transport
• general laboratory tests, including basic analysis in epidemic contexts
• transfusion
• bacteriology laboratory, Mini-Lab

The hospital kit is modular. You don’t order the hospital kit as a whole, but you order the part according the context and the activities you are carrying out.

6 main activity focal points

• OPD = out patient department: 10 000 persons/3 months
• Advanced medical post = AMP: 300 patients (50% severe)
• Emergency room: 300 severe patients
• Hospital ward: 20 to 40 beds / 300 patients
• and complementary module to the ward : delivery room: 50 deliveries
• Operating suite: 100 interventions
• Intensive care unit: 4 beds

4 support activities

These activities are mostly presented as an option

• Central sterilisation part: choose between the 90 or 39 litres autoclave
• Laboratory part: rapid diagnostic tests, equipment, reagents, …
• Central pharmacy part containing cold chain equipment
• Divers modules

The 6 main activities are composed of 2 or 3 parts each:

• Medical equipment (sometimes split into 2 parts like in the operating suite activities)
• Medicines and medical renewable supplies
• Complementary part (for OPD, advanced medical post, and ward)

In these parts, some modules are mandatory and other modules are optional.

Sometimes two articles/modules are indicated as Choice : it is mandatory to order one the two proposed choices according to the context.

The modules that are common to the different parts are called hospital modules:

The modules that are specific to a main activity are indicated by a letter in the code:

• C: OPD/consultations: 10 000 persons/3 months
• A: advanced medical post: 300 patients (50% severe)
• E: emergency room: 300 severe patients
• W: Ward: 20 to 40 beds / 300 patients
• O: Operating room: 100 interventions
• I: intensive care unit: 4 beds

4 support activities

These activities are mostly presented as options, but the sterilization and the pharmacy must be ordered with one of the main activities.

• Central sterilization part: choose the 90 litres or 39 litres autoclave
• Laboratory part: modules rapid diagnostic tests, sampling, transport, reagents, equipment, transfusion, blood bank, clinical chemistry blood analyser
• Central pharmacy part including cold chain equipment, refrigerator or deep freezer, library, stationary, and blood bank refrigerator.
• Divers modules:
• TB and ARV medicines
• Emergency box KMEDKFAI5--
• Module PEP
• Gynecology-obstetrical material
• VHF investigation module
• Module with medicines for the team
• Basic book kit
• Stationary module
• Some optional modules (injectable and oral antimalarial drugs, rape management)

Examples of use:

• Displaced camp
• OPD + Sterilisation 39l + Pharmacy
• OPD + Sterilisation 39l + Pharmacy + Observation beds
• Conflict with hospital intervention
• ER +/‐ OPD, +/‐ AMP
• Ward 30 beds/400 patients
• OT suite + 1 OT room + 100 procedures
• Sterilisation 90l
• Pharmacy
• Earthquakes
• OPD
• ER + Ward 30 beds/400 patients
• OT suite + 2 OT room + 200 procedures
• Sterilisation 90l
• Pharmacy
• Complementary delivery
• Physiotherapy module

Advanced medical post for 300 patients, of which 50% severe

• To manage medical, surgical, gynaecological/obstetrical and paediatric cases
• Severe patients must be stabilised and referred by ambulance to the hospital (2 hours drive)
• Exceptionally the patient can stay overnight
• No power
• Full treatment course for “green” ones
• 300 patients:
• 15% red = 45
• 25 % yellow = 75
• 10% black = 30
• 50% green = 150
• The presence of a medical doctor is required

It is composed of 3 parts

• Medical equipment
• Medicines and renewable medical supplies
• Complementary part if electricity available

The support activities Sterilisation and Pharmacy are mandatory in one of the 6 main activity focal points.

You will find hereafter the new organization of the TOOL KITS which includes 4 basic kits and several complementary kits for specific needs.

Basic kits

KPROKTOO1--: KIT TOOLS, basic

Basic tool set, essential in every MSF mission for small logistic jobs. This kit is complementary to KPROKTOO29-.

KPROKTOO29-: KIT TOOLS, maintenance LAND CRUISER

Tool kit essential for the maintenance and the realization of certain repairs of your Land Cruiser vehicle fleet. Could be extended upon request.

KPROKTOO3--:KIT TOOLS, workshop infrastructure

Complete equipment intended for setting up a mechanical workshop allowing vehicles maintenance and certain vehicles repairs.

KPROKTOO4--: KIT, TOOLS, carpentry

Selection of tools for carpentry jobs.

Complementary kits

KPROKTOO21-: KIT TOOLS, consumables

Selection of consumables needed in a mechanical workshop. A periodic order is to be submitted to replenish the stocks.

KPROKTOO23-: KIT TOOLS, complementary for truck

Selection of tools complementary to KPROKTOO029 intended for the maintenance and certain repairs on trucks.

KPROKTOO35-: TOOL KIT installation glued WINDSHIELD

Tools and equipment to take out an old windshield, clean the surfaces and place and hold the new windshield while the glue is drying.

KPROKTOO31-: KIT COMPRESSOR, 100 litres + accessories

Compressor with a tank volume of 100 litre and its module of accessories (to inflate inner tyres, to blow air for cleaning purposes). The module with accessories is identical for 3 different compressor kits.

A compressor is indispensable equipment for a mechanical workshop.

Make sure to check the quality of the power source (starting factor 3 to 5).

KPROKTOO311: KIT COMPRESSOR, <50 litres + accessories

Compressor with a tank volume of less or around 50 litre and its module of accessories (to inflate inner tyres, to blow air for cleaning purposes).

This kit with a compressor of +/- 50 litre (2 HP) is recommended for a mechanical workshop where the starting capacity of a compressor of 100 liters (3 HP) might be difficult.

Make sure to check the quality of the power source (starting factor 3 to 5).

KPROKTOO312: KIT COMPRESSOR, 200 litres + accessories

Compressor with a tank volume of or around 200 litre and its module of accessories (to inflate inner tyres, to blow air for cleaning purposes) as well as a module of painting accessories.

This compressor of 200 litre (3 to 4 HP) is recommended for a mechanical workshop where painting activities are done, which is an operation that requires a constant air flow.

Make sure to check the quality of the power source (starting factor 3 to 5).

KPROKTOO32-: KIT ARC WELDING unit

Arc-welding unit of inverter type and accessories, 230 V and ± 160 A. Make sure to check the quality of the power source, this equipment needs a stable power supply.

KPROKTOODRS: KIT DRILL SCREWDRIVER + accessories

Portable screwdriver/drilling machine supplied with spare battery, set of drill bits to drill in metal and screwdriver bits as well as protective goggles.

KPROKTOODRI: KIT HAMMER DRILLING machine 230V + accessories

Electrical hammer drilling equipment used to make holes. The drilling machine is supplied with a set drill bits for drilling in metal and in concrete, as well as protective goggles.

KPROKTOOGR1: KIT ANGLE GRINDER Ø125mm + accessories

Electrical tool used to cut, trim, brush and polish. Supplied with discs with diameter of 125 mm for different purposes and with protection material.

KPROKTOOGR2: KIT ANGLE GRINDER, Ø230mm + accessories

Electrical tool used to cut and trim. Supplied with discs with diameter of 230 mm for different purposes and with protection material.

KPROKTOOTW-: KIT TIN WELDING ± 80-100W, 230V + accessories

Electric heating device allowing a brazing operation, by the contribution of a metal: tin. It is used to braze electrical contacts and electronic parts.

Remark

All tools are codified according to the MSF codification system, but for certain tools, MSF uses a reference of the supplier Facom at the end of the label. Nevertheless, this does not mean that all tools sent to the field are of the brand Facom. The actual brand selected and sent, varies according to supply centres, the intended use in the field (intensive use or not) and of the availability on the market with regards to the quality-price ratio..

The nail systemis composed of the intra-medullary nails with sliding screw system needed to insert the nail.

It contains the nailing instruments set, the spare parts, the different sizes of reamers, screws and nails (=implants).

When making an initial order for the Gamma nail, one of each set should be ordered which corresponds to the management of 40 patients. Established trauma centers may need to order more implants depending on the consumption.

Used for intertrochanteric and subtrochanteric fractures of the femur.

Only orthopedic surgeons are allowed to use this set.

There has to be a certain number of intertrochanteric and subtrochanteric fractures being admitted and treated in the trauma center to justify its order since not all trauma centers admit and treat these type of fractures.

See introduction KSUI

The system is composed of a lag screw, a side plate, cortical screws and accessories to insert the screw into the site of the fracture of the proximal femur.

The Omega 3 System is indicated for closed fractures of the proximal femur which include

• simple and complicated pertrochanteric and intertrochanteric fractures
• fractures of the femoral neck and certain subtrochanteric fractures

Only orthopedic surgeons are allowed to use this set.

There has to be a certain number of of femoral neck fractures, pertrochanteric and subtrochanteric fractures being admitted and treated in the trauma center to justify its order since not all trauma centers admit and treat this type of fractures.

See introduction to KSUI

The operating suite part can be ordered only if hospital beds are already present.

The operating suite part contains general medical equipment for a maximum of 2 operating rooms.

Each operating room includes its own equipment, plus the equipment for the recovery room.

One or two operating theatres can be ordered according to the planned activities.

The supplies are calculated for 100 interventions.

The operating suite part cannot be sent if there is no skilled surgeon with anaesthetist and an OT nurse present on the spot.

It is composed of 3 main parts

1. General medical equipment for the whole operating suite and the modules of the support activities (laboratory, sterilization, divers modules, pharmacy)

2. Medical equipment part for 1 operating room (OT 1 room) + 1 recovery room. This part needs to be ordered the number of times according the number of OR.

3. Medicines and renewable medical supplies for 100 interventions

The support activities Sterilisation and Pharmacy are mandatory in one of the 6 main activity focal point.

Choice : it is mandatory to order one the two proposed choices

• In part 1 (equipment for the whole operating suite) an autoclave must be ordered: either the 39 litres autoclave (if small number of small interventions planned), either the 90 litres autoclave (that enables to sterilize all type/size of instrument sets), both presented as choices
• In part 2 (medical equipment for 1 operating room) it is mandatory to order either the manual anaesthesia circuit (Diamedica DPA 02), either the anaesthesia ventilor “Glostavent Helix”, both presented as choices.

The ward equipment part contains the necessary material for 20 to 40 beds, the medicines and renewable supplies part if for about 400 patients:

• Inpatient ward, with post‐operative care
• Option: physiotherapy/traumatology

Depending of the activities, in particular surgical ones, the equipment for additional beds must be increased.

It is composed of 3 parts

• Medical equipment part for 20 to 40 beds: this part needs to be ordered the number of times according the number of beds present in the hospital
• Medicines and renewable medical supplies for 400 patients. To be multiplied, like the equipment, according the number of patients expected.
• The Delivery part of the hospital kit is a complementary part to the ward

The support activities Sterilisation and Pharmacy are mandatory in one of the 6 main activity focal point.

A protocol for starting an orthopaedic programme with internal fixation exists for the MSF missions.

The authorization to practise internal fixations in an MSF mission must meet all the criteria listed in the reference document. They are absolute minimum criteria checked and signed by a referent before implementing such a programme.

The articles can only be used in projects where the prerequisites for internal fixation are already in place and internal fixation is ongoing with good follow up of surgical complications and surgical infections.

Only orthopedic surgeons are allowed to use these sets.

Under COVID-19 times, the procurement and validation of locally purchased Personal Protective Equipment items is becoming under pressure. Despite the pressure, we must still make sure we provide the best levels of protection to staff and patients. Often, we hear that masks are fake, there is no such item as a fake mask, there are copies, counterfeits and many different qualities. MSF provide staff and patients with the best quality PPE, but sometimes it is very difficult to tell between a good mask and a bad one. To assist with the local procurement process and to ease the pressure, a field-testing protocol has been developed to provide useful information to ease the exceptional validation process.

This testing protocol comes as a complement to the quality documentation assessment including the review of the packaging, certificates and test reports when available. The reason these masks require testing is because there is doubt about their quality, origins, and/or because the quality cannot be verified by other means (certificates, unknown manufacturer, etc).

Please follow the local purchase validation procedure in place in your OC and contact your OC Medical Device / pharma referent if you have any questions.

• Material needed. A marker, a pair of scissors, a lighter and a bottle of water
• Mask Selection. Take 6 Masks from 3 separate boxes, do not take them all from the same box and it is always best to take them from the middle of the box, not just the tope one.
• Numbering. Number the Masks 1-6 using a pen on the outside and inside. These number will be used to record the details of your finding.

General Test

Check the stitching or bonding, does it look tight, professional, neat, cover the month and nose, no loose threads, strap bonded okay, metal nose strip, is it along the full length of the mask, or only a small part. Is it comfortable to wear, is material soft and non-irritating. Masks have 3 layers, coloured on outside, 2 equal straps or ear loops, measured when flat 90 x 175 mm.

If the general test produces very bad results then it is clear the quality of the product is so bad that it cannot be used as any type of surgical masks, only you will be able to see how good or bad it is, and make the assessment based on your findings. Base your decision on the impact of your findings, are there minor faults (small parts of loose stitching or bonding, 1 or 2 areas where stitching has come off) or major (lots of bad quality, missing ear loops, very poor stitching, not very strong). Everything you could possibly find or not find can be listed here. If it is so bad, do not verify and do not send request for exceptional validation.

Score: 1 - Excellent; 2 - Good; 3 - Fair; 4 - Bad; 5 - Very Bad

Static Test

Place some very small pieces of cotton, thread or polystyrene on a table, place the masks on the thread and lift the mask up, some of the thread should stick to the masks because of the static, static is good as it improves the filtration of the masks.

Whilst it is best to have a functional filter in a surgical mask, static test is a lower priority to having a surgical mask as a good barrier between you and others. So, a poor performing static test could still be validated as a Surgical mask, if the static energy does not pick up more than a couple of pieces of thread or polystyrene. Then, it can still be sent forward for exceptional validation. Just make sure the findings are recorded in the record sheet. Even if no pieces are picked up, still useful to send for exceptional validation.

Score: 1 – Excellent, lots of pick up; 2 – Good, some pick up; 3 – Fair, 3-4 pieces picked up; 4 – Bad, only 1-3 pieces picked up; 5 - Very bad, no pieces picked up.

Water Repellent Test

Lay all masks on a clean table in order with the outside facing up, place 3-4 drops of water on the outside of the masks. The water should NOT be absorbed and should remain on the outer layer. If water is absorbed, write how long in seconds it is before the water is absorbed.

This is one of the most important tests for surgical masks, it should be repellent on the outside. If the water is absorbed into the material immediately or within 5 minutes, the mask cannot be used as a surgical mask, FAIL overall. If the water is absorbed after 5 minutes, note this in the record sheet, the mask might still be able to be used with other measures, for example using a face shield, not high-risk areas or after a specific period of time.

Score: Water absorbed: 1 - in more than 10 Minutes; 2 – in 8 minutes; 3 – in 6 minutes; 4 – in 5 minutes; 5 – in less than 5 minutes

If water is absorbed immediately, the test is a fail and the mask cannot be validated for medical or surgical use.

Water Absorbent Test

Turn the masks over, place 3-4 drops of water on the inside of the masks. The water SHOULD be absorbed into the mask over a period of time, record on record sheet how long until droplets absorbed, if no absorption write ‘repellent’.

A good quality mask should be absorbent on the inside, but it is a lower requirement to some other tests, note the time it takes to absorb, if at all. If the mask does not absorb, a request should be made for exceptional validation, but additional measures may be required.

Score: Water absorbed : 1 –immediately; 2 – in 1 minute; 3 – in 5 minutes; 4 – in 10 minutes; 5 – Water not absorbed

Filter Thickness

Using scissors, cut around the stitching of the masks so they can be taken apart. The central layer should be very tightly bound, it’s the filter part, you should not be able to see through or just being able to see through. If it is very easy to see through, it is not good like the examples below.

A good quality mask has a good quality filters, if the filter is too thin, it can still be exceptionally validated but additional measures will have to be considered, for example, only use in low risk areas, not to be used as a procedural mask etc.

Score: 1 – Excellent; 2 – Good; 3 – Fair; 4 – Bad; 5 - Very bad

Flame Test

Using a lighter, try and light the three layers of the mask one at a time. Describe what happens when exposed to flame (melts, melts and flame, catches fire easily, disintegrates or other more accurate words to describe)

A flame test is a good way of checking if a mask can be used in all areas and all procedures, if the mask does not catch fire it is good. If the mask catches fire immediately and is totally engulfed, it cannot be used in an area where there is a risk of fire or near smoking areas. If it burns, but slowly, it can be used in most areas but certainly not in high fire hazard areas like incinerator operators.

Score: 1 - No flame; 2 - Slight slow flame; 3 - Flame in less than 3 seconds; 4 - Immediate flame; 5 - Quick to catch fire and burns quickly

Recording

All the findings of each mask on the Field Testing Record Sheet below or using the Excel sheet. Put a score for each test, send the complete record sheet to Pharma reference team in HQ it and if needed, take some photographs where you are experiencing some difficulties or need more support.

Surgical mask Field Testing Record Sheet

• Manufacturer and country of manufacture
• Supplier Information + contact details
• Comments from tester (Difficult, easy, understandable, not possible, no resources for proper testing, unusual occurrences etc

A mask that has good results in all areas is clearly a good mask, it will most probably pass exceptional validation. Whereas a mask might have average test results for all tests, whilst it will be average it might produce quite a bad overall score. Before requesting exceptional validation, please make sure the need is there for these masks.

• A mask that scores 5-12 is likely to be exceptionally validated as a surgical mask to the type marked on the packing
• A mask that scores 13-19 may receive exceptional validation but additional measures are likely so it can be used as a surgical mask as a ELINMASSN00: FACE MASK, non-woven (not medical, not type IIR)
• A mask that scores 20-25 is unlikely to receive any validation so other sources of supply should be investigated. If there are no other sources of supply for this mask, a risk/benefit analysis will be discussed between HQ Pharma, Cell Med Ref, HoM, Mission Pharma, MedCo, IPC Focal Point to decide on risk mitigation measures.

Practical checking instructions and report form for rapid control at delivery

This checking procedure is meant to point out any major failure which might occur with the material. It is not meant to be an exact check up of all the physical characteristics given in the technical description. Two people are required, but it is really easier with three. It takes about 2 hours for one sample and up to six hours for six samples.

Equipment needed

Physical check of the product

• a measuring tape, 10 metre long
• a scale which measures up to 100 kg, in increments of 100 g, to weigh rolls and/or a scale which measure up to 10 kg, in increments of 10 g, to weigh tarpaulins
• a cutter knife
• a note book, a pen and as many copies of the report form as per number of samples
• a calculator
• a pair of scissors
• a 20 cm ruler
• a pocket knife
• a permanent marker

Mechanical tests

• two clamps with minimum 40 mm wide jaws
• one hook made of 8 mm diameter steel rod
• one "adjustable weight" in order to weigh 10 kg when combined with one of the clamps (i.e. a strong canvas bag filled with iron pieces)
• one weight of 70 kg (i.e. a tarpaulin bale plus the canvas bag)
• two wooden bars of 1 m in length and 4 x 4 cm² in diameter or equivalent
• one punch of 8 mm in diameter
• one hammer and some nails
• one crow bar with nail extractor

Checking procedure

Physical check

NB. Before starting the procedure, write a reference on each roll or tarpaulin to be tested, mentioning the name of the customer, the date of the test and the number of the sample (i.e. MSFKenya-23/03/2019 nr 1, 2, 3,…). This reference has to be reported in the heading of the respective report form.

• weigh the roll or the tarpaulin, without any packaging, and note the result for further calculation
• unroll, or unfold the tarpaulin and check the colour of the sheet: it should be a strong white, without significant colour fluctuation
• compare the presence of the 6 bands to the position given in the drawing (see figure 1), one can accept up to 5 cm fluctuation from the given position
• the bands must be blue
• check that there is a length indicator mark every meter, ensure that the distance between two marks is really 1 m, and check at 3 places
• check for the presence of the manufacturer name and the manufacturing date and month in letters 2.5 cm high, at least one every 6 meter on a roll and twice on a tarpaulin
• measure the width of the tarpaulin or the roll at 3 different places. Measurements must be minimum 3.96 m up to 4.04 metre.
• measure the length on the two edges and in the middle between the two central blue bands: it should be 6 metre for a tarpaulin or 60 m for a roll
• note the differences in the "comments" column of the report form.
• calculate the exact surface of the sample (length by width) and calculate the specific weight (total weight in grams divided by the surface in square meters), it must be between 209 gr/m² and 231 gr/m²
• scratch the white coating of the sheet with the cutter and check that the yarns are black in the two directions, warp and weft: NB. Light grey is not acceptable
• scratch the blue coating of the bands with the cutter and check that the yarns are black in the two directions, warp and weft: NB. Light grey is not acceptable

2. Mechanical property tests

NB. All the samples tested have to be kept until "quality clearance". In case of failure, the tarpaulin (piece or roll) has to be kept for laboratory control.

Tear test in the sheet (see figure 2).

• The test has to be performed a minimum of 4 times on different samples. Cut 4 samples lengthwise and 4 samples crosswise into the sheet (outside of the reinforced bands!). The dimensions of samples must be 6 x 20 cm² and they must be pre-cut 8 cm down the middle. On each sample note "L" for lengthwise and "C" for crosswise plus the sample reference (Sample description: see figure 2).
• Hang the first clamp with the rope to any support about 2 m high. Insert the sample into this clamp.
• Fix the second clamp to the other end of the sample. Slowly hang a weight of 10 kg (including the weight of the clamp itself) on the second clamp. Release the weight very carefully.
• Each sample should resist the weight of 10 kg. If a sample tears off, do a laboratory test to confirm or to cancel this result. The laboratory test should be a test of tensile strength and tear strength.

Tear test in the band (see figure 3).

• The test should be performed on 3 samples per tarpaulin or roll. Cut 3 pieces on 3 different bands as shown in the drawing (Sample description: see figure 3).
• Roll one end of the sample around the wooden bar several times, clamp it with the second timber and nail it.
• Place both extremities of the wooden timber on a support in order to allow the sample to hang freely (e.g. the raised forks of a forklift).
• Punch a hole of 8 mm diameter in the middle of the band at 20 cm from the border.
• Place the hook in the hole you have punched, and hang a 70 kg weight on it, avoiding any shock. To make a weight of 70 kg you can use one bale of tarpaulins, plus the additional weight you had in the previous test.
• If one of the samples tears off, further laboratory testing is required

Peeling test of the bands.

• Pull off a corner of a band from the tarpaulin with the knife and try to peel the band off just by pulling it by hand. In most of the cases you should be able to peel off the bands. If this is not the case, it means that the band has been welded too strongly, report it into the "comment" column of the report form.
• To check that the resistance to peeling is not too low, you must check that black spots remains on the white side and white spots remaining on the black side. This means that the melting of the band and the base material has been correctly done.
• If one side remains completely white and the other completely black, this counts as a failure and further laboratory testing is required.
• Repeat the whole process on three different reinforced bands.

Peeling test of welding

• If the product has a weld in the middle, perform the same peeling strength control on the weld.

Peeling of the coating

• Try to pull off the white coating from the black fabric, it should be impossible to peel pieces larger than 1 cm² or ¼ square inch.

CAUTION

Articles which are only delivered as part of a kit (motor pumps, water tanks, pipework, tools and sprayers) are not described in the Logistic Catalogue, but can be found in the Kit Catalogue (KWAT).

MSF REFERENCE DOCUMENT

"Public Health Engineering In Precarious Situations"

This guide is a reference manual for engineers, logisticians, and all those concerned with environmental health in humanitarian relief operations associated with natural disasters or conflicts.

You will find in it information on water supply, sanitation, wastewater and sewage disposal, waste management, dead body management and vector control.

The book's main focus is on technical aspects and equipment; it does not cover hygiene promotion, but gives references to other books that do.

NEEDS ASSESSMENT FOR EQUIPMENT

1. Water needed

• What is the target population? (Take account of possible fluctuations in the future.)
• Is MSF in charge of water supply for the whole population?
• What quantity of water do you plan to supply per person per day?
• 5 l is a strict minimum during the emergency phase.
• 10 l is acceptable for a transitional period.
• 20 l should be the standard for the medium and long term.
• What quantity of water do you need for medical facilities?
• Feeding centre: 30 l/person/day
• Dispensary: 5 l/consultation
• Hospital: 50 l/bed/day (40 - 60 l)

NB: You should add 15% to account for losses during distribution and transportation.

• How many distribution points are necessary?
• How many times a day can you fill the tanks?

2. Water available

• What types of water source are available? Rain, lake, river, spring, well, borehole, etc.
• How far away are these sources?
• Should transportation be by pipe or by truck?
• What is the water quality?
• Do you suspect faecal contamination?
• Do you need a water testing kit?
• In all situations, chlorination should be organised. In some cases, it should be combined with sedimentation (in 30 m³ tanks), or filtration (water treatment plant).
• Draw a plan of your camp to review your projected water supply network: how many sites, pipes, roads, access points etc.

3. Equipment needed

Taking account of the answers to the questions above and of your map, you should define your needs in terms of MSF standard kits and modules, which are presented in this catalogue.

EXAMPLE

A population of 30000 people is placed in a camp with water available 200 m away. MSF is responsible for providing water to the whole camp for 2 months.

Water needed

• For the population: 30000 people x 10 litre/person (transitional period) = 300 m³/day
• For the medical facilities:
• feeding centre: 80 patients x 30 litre/patient/day = 2400 litre/day
• hospital: 20 beds x 50 litre/bed/day = 1000 litre/day
• total: 3400 litre/day
• Total water required: 300 + 3.4 + 15% = 350 m³/day

Distribution

• For the population:
• 1 distribution ramp = 6 taps = 6 x 250 people = 1500 people
• 30000/1500 = 20 ramps = 10 water distribution modules
• rule of thumb:
• minimum storage = 5 l / person
• => 30000 x 5 l = 150 m³ total storage capacity required
• => 150 m³ / 15 m³ tank = 10 tanks to be ordered
• For the medical facilities:
• 2 days' storage capacity is mandatory
• feeding centre: 2.4 m³ x 2 days = 4.8 m³ => order tank of 5 m³
• hospital: 1 m³ x 2 days = 2 m³ => order tank of 2 m³
• The facilities, being a long way from the river, will be supplied by a 5 m³ tanker truck.

Sedimentation

• A tank of 30 m³ has a height of 1.5 m. Sedimentation takes place at 100 cm/hr.
• 150/100 = 1.5 hrs to 2 hrs is needed for the sedimentation of a full tank + count 1 hr for filling the tank and 1 hr for emptying it => total time required = 3.5 to 4 hrs
• 5 batches of 25 m³ can be made in one day (no night work) => one tank can produce 125 m³ per day
• Tanks required: 350 m³/ 125 m³ = 3 tanks of 30 m³ are needed

Water chlorination

• 1 kit contains 15 kg of chlorine, enough for 10,000 people for one week => for 30,000 people 3 kits are necessary
• Additional chlorine calculations: for 30,000 people over two months, 405 kg of chlorine are necessary. Minus the first 45 kg in the kits => order 360 kg of chlorine

Water pumps

• 1 pump for sedimentation
• 1 pump for tanker truck
• 2 pumps for the rest of the distribution
• (diesel or petrol, depending on the fuel available)

Piping

• The map of the network shows a total requirement of 480 m of piping.
• The kits (pumps and tanks) already provide a significant quantity of piping, so order 2 modules of additional piping to complete.

Others

• 2 water supply toolkits
• 2 2"/3" adaptation kits

Hand pumps

Hand pumps are manually operated pumps, using human power to lift water from boreholes or wells.

Different hand pump types are used, depending on the depth of the water level, the required yield and the pumps available.

When choosing a hand pump, always keep in mind that the column of water is getting very heavy at greater depth and can be very difficult to lift, especially for women and children who are mainly responsible for collecting water.

Antiseptics are used to kill or eliminate microorganisms and/or inactivate viruses on living tissues, including intact or broken skin and mucous membranes.

The following table provides an overview of the standard antiseptics mentioned in the MSF catalogue.

MSF Specifications

MSF provides PVC-free containers for use in anaesthesia and emergency care, and for the injection of drugs (including cytostatics) and additives.

PVC containers should not be used for the preparation and administration of cytostatics, nor in neonatology, obstetrics, or paediatrics.

Containers

Infusion containers should be unbreakable and collapsible (closed system).

• PVC is not recommended because it releases phthalates (DEHP) and can adsorb certain medicines. For example, it is incompatible with cytostatics and certain drugs like amiodarone. Its use is also not recommended in neonatology, obstetrics, and paediatrics. Since 2020, PVC flexible bags are no longer the MSF standard.
• Flexible PVC-free bags offer the most advantageous logistic properties, including low volume and low weight.
• Semi-rigid PVC-free bottles made of PE (polyethylene) or PP (polypropylene) remain standard for specific products where there is no. or only a limited number of sources available of PVC-free flexible bags. They also provide benefits in specific situations, such as when large volumes need to be injected into the infusion solution or when a container that can stand upright is required.

Injection sites

Containers should have two injection sites, both protected from contamination:

• 1 site for adapting the infusion set
• 1 additional site for the possible addition of medicines (beware of incompatibilities). Use specific labels to indicate the medicines added to the infusion.

Container closure system

• The elastomer closure should be firm enough to allow a needle to pass through with the minimum release of particles.
• The Eurohead cap system offers the best option against the risk of contamination. Blow-fill-seal bottles are manufactured with a flattened head, and the Eurohead device is inserted in non-aseptic class before the entire system is autoclaved.
• The Nipple head system should be avoided due to the risk of microbial contamination through micro-leaks in the primary packaging.

Secondary packaging

To prevent containers, especially flexible bags, from being compressed under their own weight and to avoid fatigue points at the closure system (which can lead to the formation of micro-holes), the secondary packaging (carton box) should meet some specifications:

• Strong enough to withstand transport conditions.
• The box should be tested for compressive strength and bursting strength, based on the height of the stack and the weight of the box.
• The manufacturer should provide documentation of the compressive strength value of the packaging.

Infusion set

The infusions are supplied without infusion sets.

• Infusions sets should be ordered separately.
• Infusion fluids and infusion sets are supplied in separate packages. The corresponding quantities should be packed together before delivery to health facilities.

Insulin categories

Insulin is available in two main forms: human insulin and analogues of human insulin.

Human insulin is a synthetic version of insulin that exactly replicates the structure of natural insulin. However, when injected under the skin, it differs from natural insulin in that it tends to aggregate and has a longer absorption time.

Insulin analogues are also synthetic insulins designed to closely mimic the body's natural insulin release. The amino acid sequence of insulin analogues is altered compared to human insulin to modify its pharmacokinetic properties. Once absorbed, it works similarly to human insulin but with more predictable absorption. Insulin analogues are more expensive than human insulin.

Insulin characteristics

Insulins are classified based on their action profile, which include:

• Onset of action: the time it takes for insulin to start acting
• Peak action: the at which insulin reaches its maximum effectiveness
• Duration of action: the length of time the insulin remains effective

Insulin types

Insulin types are generally categorised into three main groups: Rapid-acting (or short-acting), Intermediate-acting, and Long-acting.

Rapid-acting insulin (or Short-acting)

• Rapidly absorbed from fat tissue (subcutaneous) into the bloodstream.
• Intended to provide the necessary bolus or prandial insulin.
• Used to control blood glucose levels during meals, snacks, and to correct hyperglycaemia.

Includes:

Regular Human Insulin

• Onset: approx. 30 min
• Peak: in 2 to 4 hours
• Duration: 6 to 8 hours
• The higher the dose, the faster the onset, but the longer the time to peak and the longer the duration of effect.
• Less predictable than rapid-acting insulin analogues.
• Administered at least 30 minutes before meals to reduce postprandial glucose levels.
• Examples: Actrapid^®, Humulin R^®

(Ultra-) Rapid-Acting Insulin Analogues (insulin Aspart, insulin Lispro, insulin Glulisine)

• Onset: 5 to15 minutes
• Peak: in 1 to 2 hours
• Duration: 4 to 6 hours
• Regardless the dose, the onset and peak time remain similar.
• The duration of action varies with the dose: few units may last 4 hours or less, while a larger dose (25 or 30 units) may last 5 to 6 hours. As a general rule, these insulins are considered to have a duration of action of 4 hours.
• Administered during meals to correct high blood glucose levels.
• Examples: Humalog^® (insulin Lispro), Novorapid^/® (insulin Aspart), Apidra^® (insulin Glulisine)

Intermediate-acting insulin

• Absorbed more slowly, with a longer duration of action.
• Intended to provide the necessary basal insulin (when administered at bedtime) or prandial insulin (when administered in the morning).
• Used to control blood glucose levels between meals and overnight.

Includes:

Isophane (NPH) Human Insulin

• NPH : Neutral Protamine Hagedornis
• A fish protein, protamine, has been added to regular human insulin to delay its absorption. As NPH is a suspension of different sized crystals, its absorption and action time are highly unpredictable.
• Onset: 1 to 2 hours
• Peak: in 4 to 12 hours
• Duration: 14 to 18 hours
• A small dose given before meals results in an earlier peak and shorter duration of action (to cover needs between meals), while a higher dose given at bedtime will have a longer peak effect and a longer duration of action.
• Examples: Insulatard^®, Humulin N^®

Premixed Insulin (or Biphasic insulin)

• NPH premixed with regular human insulin or rapid-acting insulin analogs.
• Combines the action profile of rapid-acting and intermediate-acting insulins:
• Onset: 30 to 60 minutes
• Peak: in 2 to 8 hours
• Duration: 10 to 16 hours
• Includes various combinations:
• NPH mixed with regular human insulin in a 70:30 ratio (70% NPH, 30% Regular). e.g. Mixtard 30^®
• NPH mixed with rapid-acting insulin analogue Lyspro in a 75:25 ratio (75% NPH, 25% insulin Lyspro). e.g. Humalog Mix 75/25^®
• NPH mixed with rapid-acting insulin analogue Aspart in a 70:30 ratio (70% NPH, 30% Aspart). e.g. NovoMix 30^®

Long-acting insulin (or Prolonged-acting)

• Absorbed slowly, with minimal peak and a stable, prolonged effect lasting from 8 to 24 hours.
• Intended to provide basal insulin needed throughout the day, especially at night.
• Used to control blood glucose levels overnight, while fasting, and between meals.

Includes:

Long-acting insulin analogues (Glargine insulin, Detemir insulin, Degludec insulin)

• Onset: 3 to 6 hours (for Glargine insulin)
• Peak: over the next few hours
• Duration: relatively stable for 12 to 24 hours with Detemir insulin and 24 hours for Glargine insulin
• Examples: Levemir^® (Detemir insulin), Lantus^® (Glargine insulin), Tresiba^® (Degludec insulin, ultra-long-acting)

Storage

Any unopened insulin container should be stored in a refrigerator between 2°C and 8°C.

Once in use, Insulin vials or pens can be kept at room temperature, between 15°C and 30°C, for approximatively 1 month. Insulin detemir can be stored at room temperature for up to 42 days.

Do not freeze insulin and protect it from light.

Exposure to high temperatures can reduce insulin efficacy and compromise glycaemia control.

Regular insulin, basal insulin analogues (such as glargine, detemir, and degludec), and rapid-acting insulin analogues (such as lispro, aspart, and glulisine) are clear and colourless. They should not be used if they appear cloudy or viscous.

Insulin therapy

Insulin doses are expressed in units.

It is not recommended to switch a patient from one type of insulin to another. Changes in concentration, brand (manufacturer), type, origin (human insulin or human insulin analogue), and/or method of manufacture may require adjusting the dose.

Insulin is administered by subcutaneous injection using either a syringe marked with insulin units and a needle, or a pre-filled pen. Insulin pumps are not par of MSF Standard.

For pre-filled pens, only use specific needles designed for theses types of pen.

MSF codes and labels for insulins

All insulins have a concentration of 100 IU/ml, as indicated on the label (but not in the code).

• Type of insulin
• DINJINSA+++: analogue insulin
• DINJINSH+++: human insulin
• Duration of action
• B = biphasic: the ratio is identified in the label: fast / long-acting
• L = long-acting analogue insulin
• U = ultra-rapid analogue insulin
• I = intermediate / isophane human insulin
• R = rapid-acting human insulin
• Volume / Quantity
• 1 = 10 ml
• 3 = 3 ml
• Insulin presentation:
• V: 10 ml vial
• C: 3 ml cartridge, for use with a reusable auto-injector
• AP: 3 ml pre-filled pen (single-use insulin pen)
• Manufacturer: last letter of code and label
• L = Lilly
• N = Novo Nordisk
• S = Sanofi

All vaccines supplied by MSF are pre-qualified by the WHO. If pre-qualified vaccines are unavailable, , MSF will procure vaccines without pre-qualification label but are licenced by stringent regulatory authorities. Before ordering vaccines, verify any specific requirements related to national vaccine policy (strains, VVM, ...) and regulatory bodies.

THERMOSENSITIVE PRODUCTS AND COLD CHAIN

(Cf Introduction: Thermosensitive products and Cold chain)

Vaccines, along with most medicines and rapid diagnostic tests, are highly sensitive to light and temperature. Exposure to heat and/or freezing conditions can negatively affect their quality, safety, and efficacy.

Thermosensitive codes are defined only for storage and transport temperature requirements. They are aligned with the typical (or targeted) storage facilities in the field (freezers, refrigerators, pharmacies, medical warehouses, or transport vehicles) and their target temperature ranges.

In medical catalogues and ordering tools, all thermosensitive products are associated with a thermosensitive code, as listed in the table below.

All thermosensitive vaccines with the code 0208 should be stored in a refrigerator and transported in cold chain. The "cold chain" refers to all means used to transport and store thermosensitive products at temperature between +2ºC and +8ºC.

HOW TO ENSURE THE EFFECTIVENESS OF THERMOSENSITIVE PRODUCTS

In general

• Pay particular attention to storage and transport conditions.
• Some vaccines, medicines and rapid diagnostic tests transported in cold chain may be severely damaged by freezing:
• Use only icepacks filled with cold water for transport. Place them in the refrigerator for at least 12 hours. Icepacks pre-filled with eutectic liquid (coloured gel) are not suitable because their freezing point may be below 0ºC.
• Allow frozen icepacks to warm to 0ºC before placing them in the cold box. Let them at room temperature for at least 30 minutes until they "sweat" and liquid appears in the ice-packs.

Vaccines

In accordance with WHO recommendations:

• Some vaccines are labelled with a WHO CTC (Controlled Temperature Chain) pre-qualification. This means:
• The vaccine is stable and can be stored for up to 3 days at ambient temperature not exceeding 40°C, immediately before administration, provided the VVM has not reached its limit and the expiry date is still valid.
• Any unused vaccines after a CTC excursion must be discarded.
• For CTC use: see the related article CARD indicator for overrun +40°C (Temptime) irreversible (PCOLMONICTB)
• CTC Implementation should only be done after proper planning and training.
• Currently, three vaccine are pre-qualified with a CTC label:
• oral cholera vaccine Shanchol (DVACVCHO1V-) (40°C/14 days)
• meningococcal A conjugate vaccine 1-29 years; MenAfriVac 10mcg (DVACVMENA1VD) (40°C/4 days)
• 4-valent HPV vaccine (DVACVHPV4V- Gardasil) (42°C/3 days): contact your medical department
• Freezing of vaccines:
• WHO no longer recommends freezing vaccines, except for the oral polio vaccine at national and regional levels.
• BCG, measles, yellow fever, meningitis and Hib vaccines should be stored between +2ºC and +8ºC but should not be frozen. Freezing does not affect these vaccines but is unnecessary (except in some exceptional situations).
• Diluents:
• Diluents should be kept at the same temperature as the vaccines (between 2ºC and 8ºC) during reconstitution. While not required to be stored in a refrigerator, the necessary quantity of diluent should be placed in a refrigerator or cool box 24 hours before use. Diluents should never be frozen.

THE VACCINE VIAL MONITOR (VVM)

Heat exposure of a vaccine is cumulative.

The VVM is a thermosensitive label placed on vaccine vials to indicate whether the vaccine has been exposed to excessive temperatures over time. The combined effects of time and temperature cause a gradual, irreversible colour change in the VVM.

VVMs are designed based on the stability curve of each vaccine, with an additional safety margin. The heat response levels are specific to the four models of VVM, depending on their heat stability (see table 1):

The VVM clearly indicates if a vaccine can be used or not (see figure 2).

Not all vaccine vials have a VVM. Preferably use vaccines with a VVM.

Caution, the VVM does not replace other temperature indicators. Clearly, a vaccine with a correct VVM but an expiry date passed cannot be used.

COLD CHAIN MANAGEMENT

MSF only supplies equipment that has been pre-qualified by WHO (PQS). Before ordering cold chan equipment, consult your technical department, as incorrect selection can lead to significant vaccines/medicines/rapid diagnostic tests losses, delays in the programme, or worse, the use of ineffective products.

Proper maintenance is essential for all cold chain equipment and should be performed regularly to ensure equipment remains in good condition. Details of these tasks can be found in the relevant technical documentation and guidelines.

Cold chain equipment is divided into two main categories:

Active cold chain: This category includes equipment that requires energy to produce and maintain cold. It is mainly used for storage or icepack production. Equipment in this category includes:

• ice-lined refrigerators
• freezers (for icepack production or storage of F-20 products)
• cold rooms

Passive cold chain: This category includes equipment that requires pre-conditioned ice-packs to maintain cold. It includes:

• isothermal/cold boxes
• vaccine carriers.
• icepacks

The selection of cold chain equipment (PCOL) depends on factors such as the required vaccine storage capacity, cold life, weight, and volume of the box (depending on the transport mode), and the number of ice-packs needed. Refer to the PCOL catalogue for manufacturer's specification and item details.

Practical recommendations

It is essential to always qualify refrigerators before using them for storing medicines. You can seek support from your cold chain referent and your MSF procurement centre to assist with the qualification process.

Designate and train a person responsible for the cold chain, along with a backup, to manage:

Temperature monitoring

Thermosensitive items must be continuously monitored for temperature throughout their lifecycle, using standard tools from the PCOL catalogue, such as:

• alcohol thermometers
• freezing indicators (FreezeTag^®)
• historical data loggers (LogTag^®)
• remote monitoring and alerts (BluLog^®)

For more details on their use and configuration, refer to the specific guidelines and protocols provided by your OC.

Stock management

• Prepare a contingency plan in case of a cold chain break, including:
• isothermal containers for storing the most sensitive products
• sufficient frozen icepacks and their renewal (based on the number and type of cold boxes)
• a list of products categorised by thermosensitivity to quickly determine the appropriate action
• Carefully document any breakdown (duration, temperatures reached, and exposed products) and consult the pharmacist in the medical department to decide on the appropriate actions.
• Store thermosensitive products based on their expiry date (first expired, first out).
• Do not store food or beverages in medical refrigerators or freezers.

Transport

• During distribution, protect products that should not be frozen, as the risk is particularly high at this stage.
• Develop procedures for the transport of thermosensitive products and for the preparation of cold boxes.
• Place cardboard between the products and icepacks to prevent direct contact.

Assessment of the existing cold chain

• Is the quality of the cold chain satisfactory?
• Have the refrigerators been qualified and is the qualification report available?
• Have the procedures for cold chain management been defined and are they available?
• Is the equipment suitable for your needs in terms of volume and performance?
• Is the equipment in good working order?
• How reliable is the power supply?
• Is the equipment permanently accessible?
• Are the refrigerators and freezers located in cool, clean rooms?
• Is there sufficient capacity to store all thermosensitive products and to freeze icepacks?
• Is the monitoring equipment in each refrigerator / freezer complete and functional?
• Are procedures in place for monitoring thermosensitive products on arrival and departure?
• Are the temperature charts filled in correctly twice a day?

Needs assessment

• What is the nature of your activities (routine immunisation, immunisation campaign, laboratory...)?
• How much storage capacity do you need?

The volume of vaccines varies according to the presentation and the manufacturer.

For 1 dose in a 10-dose vial of injectable vaccines you need 2 to 3 cm³.

To store 1,000 doses, you need:

• 2 litres if 2 cm³/ dose
• 3 litres if 3 cm³/ dose
• 2.5 litres if 2.5 cm³/ dose

Caution

Newly introduced vaccines (rotavirus, cholera...) are often more voluminous. Always check when ordering.

To find out the volume of medicines and diagnostic tests, contact your supply centre.

• How much freezing capacity do you need for the icepacks?
• How many cold boxes, vaccine carriers and icepacks do you need?
• What monitoring tools do you need to order (thermometers, freezing indicators, …)?

WHO RECOMMENDATIONS ON OPEN VIALS OF VACCINE

The term "open vial" refers to a vaccine vial of which one or more doses have been used during a vaccination session.

WHO Policy statement: Multi-dose Vial P (MDVP), Revision 2014
https://apps.who.int/iris/handle/10665/135972

The WHO recommendations apply only to vaccines that meet WHO specifications for efficacy and thermostability and contain an adequate amount of preservative. The vaccines provided by MSF meet these requirements.

• The location of the VVM gives a first indication of the application of the multi-dose vial policy:
• If the VVM is on the vaccine label: the vaccine vial, once opened, can be stored for subsequent vaccination sessions for up to 28 days, regardless of the product formulation (liquid or freeze-dried)
• If the VVM is attached in a different place from the label: the vaccine vial should be discarded at the end of the vaccination session or within 6 hrs of opening, whichever comes first, regardless of product formulation.
• Check the vaccine leaflet to ensure that the use of a specific product is permitted up to 28 days after opening.
• In order to implement the multi-dose vial policy, good injection practices should be followed at all times. For example, a new sterile syringe and needle must be used for each injection, and the needle must never be left inside the vial. In addition, the septum should not be contaminated or have been immersed in water, and there must be no visible contamination of the contents of the vial. Any vaccine vial without a label or with an illegible label should never be used.

Caution

Always check the national protocol for the use of open vials.

VACCINE ORDERS

Orders are always done in number of doses and not in number of vials!

Formula for a first order

Number of doses needed = target population x coverage objective x number of doses per person (according to the vaccination schedule) x loss factor + reserve stock (e.g. 25%)

Formula for subsequent orders

Number of doses needed – number of doses in stock

Loss multiplying factor

The loss multiplying factor is used to calculate the real number of doses to be ordered to vaccinate the target population, taking into account the estimated loss according to the vaccination strategy (routine immunisation activities or mass campaign), the type of vaccine (freeze-dried or liquid) and its presentation (multi-dose or mono-dose).

• For routine immunisation activities:

=> BCG : x 2 (50% loss)

=> Other vaccines : x 1.05 to 1.66 (5 to 40% loss) or specific data available for your activities

• For vaccination campaigns or in-country (national programme):

=> x 1.17 (15% loss)

The multiplying factor is a standard factor based on experience to calculate the first order. For a long-term programme, it should be adapted according to real losses or specific data available on the vaccine (in consultation with the medical department).

Example:

• Initial order of DTP-Hib-HepB for vaccination of children aged 0-11 months:
• Total population = 50,000 inhabitants
• Target population (4%) = 2,000 persons
• Coverage 100% (x 1) = 2,000 persons
• Number of doses (x 3) = 6,000 doses
• Number of doses + loss (x 1.17) = 7020 doses
• Number of doses + loss (x 1.17) + reserve (x 1.25) = 8,775 doses/year

=> Need for three months => 2,194 doses

• Order for the next three months:
• Estimated needs for three months = 2,194 doses
• Number of doses in stock = 220 doses

=> To be ordered: 2,194 - 220 = 1,974 doses

• Calculation of the storage volume
• for example: 1 dose = 3 cm³
• 2,194 x 3 cm³ = 6,582 cm³
• 6,582 cm³ / 1,000 = 6.6 litres (1 litre = 1,000 cm³)

REFERENCE DOCUMENTS

• Temperature sensitivity of vaccines (WHO/IVB/06.10)
• Essential drugs, MSF - L014DRUM01E-P
• Clinical guidelines, MSF - L002CLIM01E-P
• Management of a measles epidemic, MSF - L003MEAM01E-P
• Cold Chain Management guideline - 1st edition 2022 - L049COLM08E-P
• Logistics catalogue (cold chain family), MSF - L045CATM07EFP

PRECONDITIONS

Prior to implementing X-ray services or installing new equipment, it is essential to:

• Inquire about national radiation regulations as this may impact; equipment selection, X-ray room design, radiation safety requirements, licensing, HR staffing requirements etc
• Contact the Diagnostic Imaging Working Group (diagnostic-network@msf.org) for support and to:
• select the most appropriate x-ray equipment or assess the functioning of existing equipment
• organize the installation, implementation, maintenance and technical support
• assess the x-ray room and the need for general and personal protective equipment
• arrange training and implementation of MSF policies and procedures
• assess and/or provide training on appropriate clincal indications (use of X-ray) & X-ray interpretation for the medical team

GENERAL RADIOPROTECTION MEASURES

Staff and patients’ attendants protection

• Time, distance and shielding are the fundamentals of radioprotection measures
• Time
• Where appropriate reduce the time near the X-ray source. Limit access to the x-ray room to only those people absolutely necessary.
• Distance
• One of the most simple and effective measures. Increase your distance from the X-ray machine and patient when taking radiographs - in particular when using a mobile X-ray to decrease your dose (inverse square law).
• Shielding
• Fixed X-ray rooms are designed to protect the operators by providing a protective barrier (e.g. lead lined walls and lead glass window).
• Operators using a mobile X-ray wear radioprotective clothing (lead or lead equivalent material apron & thyroid protection).
• Extra
• Any person staying beside patient when taking a radiograph must:
• stand as far as away from the radiation beam
• wear individual radioprotective clothing (lead or lead equivalent material apron & thyroid protection).

Protection of patients

• Justification: only x-ray a patient when it is clinically indicated. See MSF X-ray indications.
• Optimization - ALARA, use the lowest reasonable dose for the specfic patient / examination that produces a quality image. See MSF X-ray exposure chart (requires trained radiographers).
• Ensure appropriate radiographic technique is used for each examination, including restricting the X-ray beam to the area of interest (collimation), correct X-ray equipment use, patient communication and positioning supports are available.
• Ensure an appropriate policy is in place for screening potentially pregnant patients prior to performing X-ray imaging.

MEASUREMENT OF RADIATION DOSES

Before starting an x-ray program, it is essential to:

• Inquire about national regulations concerning radioprotection
• Check if there is a national organisation in charge to monitor x-ray doses by dosimetry and try to install a similar monitoring system

For more information, contact the Diagnostic Imaging Working Group (diagnostic-network@msf.org).

SELECTING AN X-RAY MACHINE

The most appropriate X-ray equipment will depend on the specific project requirements. The WHIS-RAD or MULTI-RAD x-ray unit is generally preferred as the primary option for MSF hospital based projects, but may not be suitable in all scenarios. Before ordering an x-ray unit, please contact the Diagnostic Imaging Working Group (diagnostic-network@msf.org) for advice, and to discuss radiation safety requirements, human resources requirements, servicing and necessary accessory equipment.

Definition

The EEMD (Electro mechanical medical devices) family includes medical equipment and their accessories, consumables and spare-parts that operate on electrical energy and/or through some integrated physical mechanism or machinery (mechanical).

MSF guide

See the MSF guide that each mission should have and read!

• Medical equipment management guideline, MSF, 2021

MSF codification

Each equipment is identified with a specific root of 3 letters, with an additional letter defining the category of the article

• +E for the equipment = Medical devices requiring calibration, maintenance, repair, user training and decommissioning (the machine, the apparatus, also called parent device)
• +P for the equipment including the necessary package of accessories/consumables and spare-parts to have the machine operational
• +A for the accessories = Supplementary reusable parts or devices, used in combination with an item of medical equipment, to provide specific or additional functionality (e.g. ultrasound probes, barcode scanner, transport bag, warming sleeve).
• +C for the related consumables = Items requiring periodic replacement. Replacement can be required in order to reduce cross-infection risks (e.g. cannula, mask, anti-bacterial filter, syringe, tubing, etc.) or to ensure continued performance of the device (e.g. air (dust) filters, gaskets, etc.)
• +S for the different spare-parts = Integral components which are replaced in order to restore functioning, safety or physical integrity of the equipment. Spare parts can either be purchased new or, when within manufacturers tolerances and local legislation, be removed and retained for future use during decommissioning of equipment.

Further specification of the code: qualifier per brand, by sequential counting/numbering.

The person defining the needs of the accessories, consumables and spare-parts is

• for accessories => medical staff
• for consumables => logistical or medical staff, depending on the type of consumable: for use (medical) or for technical maintenance (logistical)
• for spare-parts => logistical staff

MSF articles

The different roots for the standard equipment are

Other families do also contain electro mechanical medical devices: EANE, EDIM, ELAE, ESTE.

Components of equipment

When ordering medical equipment EEMD***E, certain accessories and consumables are delivered with the equipment: they are listed in the technical sheet under “components” and/or “supplied with the article”. These additions are supplied by the manufacturer and/or compiled by the MSF Supply Centres (ESC's) to go with the equipment. This ensures that the equipment can be used correctly upon arrival in the MSF project.

Norms

General standard

IEC = International Electrotechnical Commission

IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005+AMD1:2012 +AMD2:2020) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

• IEC 60601-1 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission
• It concerns any type of medical electrical equipment without distinction
• It is presented in ten sections
• General: Scope and purpose of the standard. Terminology and definitions, general characteristics of devices.
• Environmental conditions
• Protection against electric shock
• Protection against mechanical shock
• Protection against risks due to unwanted or excessive radiation
• Protection against ignition hazards of flammable anesthetic mixtures
• Protection against excessive temperatures and other risks.
• Accuracy of operating characteristics and protection against hazardous output characteristics.
• Abnormal operation and fault conditions, environmental testing.
• Construction rules

The European EN version of the standard is identical to the IEC standard.

The equipment and all accessories selected by MSF are tested according the primary standard governing medical device design.

Collateral standards

Collateral standards (numbered 60601-1-X) define the requirements for certain aspects of safety and performance, or protection for diagnostic use of X-rays.

• IEC 60601-1-2: Electromagnetic disturbances - Requirements and tests
• IEC 60601-1-3: Radiation protection in diagnostic X-ray equipment
• IEC 60601-1-6: Usability
• IEC 60601-1-8: General requirements, tests and guidance for alarm systems
• IEC 60601-1-9: Requirements for environmentally conscious design
• IEC 60601-1-10: Requirements for the development of physiologic closed-loop controllers
• IEC 60601-1-12: Requirements for medical electrical equipment/systems intended for use in the emergency medical services environment

Particular standards

Particular standards for the medical electrical equipment, numbered 60601-2-X / 80601-2-X define the requirements for specific products or specific measurements built into products. These quality standards are listed in the technical sheets per equipment under the “norms”.

• EN 60601-2-2 : Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• EN 60601-2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
• EN 60601-2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
• EN 60601-2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
• EN 80601-2-12: Particular requirements for basic safety and essential performance of critical care ventilators
• EN 80601-2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
• EN 60601-2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
• EN 60601-2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
• EN 60601-2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
• EN 60601-2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
• EN 60601-2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
• EN 80601-2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
• EN 60601-2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
• EN 80601-2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
• EN 60601-2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• EN 60601-2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
• EN 60601-2-43 : Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
• EN 60601-2-46: Particular requirements for the basic safety and essential performance of operating tables
• EN 80601-2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
• EN 60601-2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
• EN 60601-2-52: Particular requirements for basic safety and essential performance of medical beds
• EN 60601-2-54 : Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy electrocardiographs
• EN 80601-2-55 : Particular requirements for the basic safety and essential performance of respiratory gas monitors
• EN 80601-2-56 : Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
• EN 60601-2-57 : Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
• EN 80601-2-61 : Particular requirements for basic safety and essential performance of pulse oximeter equipment
• EN 80601-2-67 : Particular requirements for basic safety and essential performance of oxygen-conserving equipment
• EN 80601-2-69 : Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
• EN 80601-2-74 : Particular requirements for basic safety and essential performance of respiratory humidifying equipment
• EN 80601-2-79 : Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
• EN 80601-2-80 : Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
• EN 80601-2-84: Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

Protection against electric shocks‌

The IEC 60601-1 standard has a significant impact on the product development process, going beyond performance test and verification. This is because product complexity generally yields innumerable potential test cases, permutations, and combinations in both normal and abnormal operating modes, and these cannot be assessed in the final design alone.

While power supplies by themselves are not medical devices and, are therefore, not directly covered by the IEC 60606-1 standard, they are nevertheless integral to the design and operation of medical equipment.

Protection method

All electrical equipment is categorised into classes according to the method of protection against electric shock that is used.This decribes the way the electric equipment is protected agains electric shocks: by being connected to the ground, by double casing ….

For mains powered electrical equipment there are usually two levels of protection used, called "basic" and "supplementary" protection. The supplementary protection is intended to come into action in the event of failure of the basic protection.

• Class I equipment: insulation between live parts and exposed conductive parts with supplementary protection: 3^rd protective earth reference point. Symbols seen on earthed equipment
• Class II equipment: Reinforced insulation or double insulation
• Class III equipment: internal power supply or SELV, Very Low Voltage Safety:
• Max 25 V AC (alternating current)
• Max 60 V DC (direct current)

Degree of protection

The degree of protection for medical electrical equipment is defined by the type designation. The reason for the existence of type designations is that different pieces of medical electrical equipment have different areas of application and therefore different electrical safety requirements.

B, BF or CF are classifications of applied parts = parts of the medical device which come in physical contact with the patient.

Types are assigned according to the level of protection to leakage currents

• Type B
• B = "Body"
• equipment operates within a 2 meter radius from the patient but without patient contact
• medical device with non-floating inputs
• average level of electrical protection of the patient
• Type BF
• BF = "Body Floating"
• equipment makes physical contact with the patient
• medical device with floating inputs
• average level of electrical protection of the patient
• CF type
• CF = "Cardiac Floating"
• makes physical contact with the heart
• medical device with floating inputs
• high level of electrical protection of the patient

Degrees of protection provided by enclosures (IP Code)

IEC 60529:1989+AMD1:1999+AMD2:2013

The different degrees of protection described in the standard are

• protection of persons against access to hazardous parts inside the enclosure
• protection of the equipment inside the enclosure against ingress of solid foreign objects
• protection of the equipment inside the enclosure against harmful effects due to the ingress of water

The protection index (IP) indicates the degree of protection of a material against the ingress of solids and liquids.

The format of the index, given by the IEC 60529 standard, is IPyy where the characters y are two numbers and/or a letter. The numbers indicate compliance with the conditions summarised in the tables below. Where no criteria are met, the number may be replaced by the letter X.

Protection against ingress of solid foreign bodies

Protection against ingress of liquids

Protection against access to hazardous parts

Waste of electrical and electronic equipment (WEEE)

WEEE is a complex mixture of materials and components that because of their hazardous content, and if not properly managed, can cause major environmental and health problems. Moreover, the production of modern electronics requires the use of scarce and expensive resources. To improve the environmental management of WEEE and to contribute to a circular economy and enhance resource efficiency the improvement of collection, treatment and recycling of electronics at the end of their life is essential.

To address these problems pieces of EU legislation have been put in place:

• The Directive on waste electrical and electronic equipment (Directive 2012/19/EU = WEEE Directive) which sets collection, recycling and recovery targets for electrical goods.
• The Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS Directive) which specifies maximum levels for 10 substances (heavy metals and phthalates)

Substances subject to limitations as referred to in Article 4 (1) and maximum concentration values by weight in homogeneous materials

• Lead (0.1%)
• Mercury (0.1%)
• Cadmium (0.01%)
• Hexavalent chromium (0.1%)
• Polybrominated biphenyls (PBB) (0.1%)
• Polybrominated diphenyl ethers (PBDEs) (0.1%)

Regarding the disposal of the equipment / apparatus: it must be dismantled and all pieces must be segregated based on matter used: plastic, metallic (iron, aluminium, ...), electronic

• WARNING: All electronic parts are classified as WEEE, sub-category of Hazardous waste.
• Most of consumables can be burnt in a normal incinerator.

Contact your WatSan and Biomedical advisors to receive the detailled procedure about management of each waste parts.

Quality standards related to batteries

• IEC 62133, 2017: Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems, Part2: Lithium systems​ (AMD1:2021)

The use of batteries in medical equipment

Types of batteries

Transport of batteries

US Regulations for batteries: all batteries, regardless of chemistry (e.g., alkaline, lithium, lead, nickel metal hydride, carbon zinc, etc., or battery powered products) are subject to 49 CFR 173.21(c) in the U.S. hazardous materials regulations.

Lithium ion and lithium metal cells and batteries

Lithium ion and lithium metal cells and batteries are subject to specific packaging, marking, labeling, and shipping paper requirements.

The regulations that govern the transport of lithium ion and lithium metal cells and batteries are very complex.

Classification (DGR 3.9.2.6): Lithium batteries are classified in Class 9 – Miscellaneous dangerous goods as:

• UN 3090, Lithium metal batteries; and
• UN 3480, Lithium ion batteries

or, if inside a piece of equipment or packed separately with a piece of equipment to power that equipment as:

• UN 3091, Lithium metal batteries contained in or packed with equipment; and
• UN 3481, Lithium ion batteries contained in or packed with equipment.

Since 2016, all lithium ion cells and batteries (UN 3480) and lithium metal cells and batteries (UN 3090) shipped by themselves are forbidden for transport as cargo on passenger planes. Transporting the batteries is organized by Packaging Instructions (PI) numbers. All packages must bear a «Cargo Aircraft Only» label, in addition to existing marks and/or labels.

Lead acid batteries

Lead acid batteries are listed as Class 8 Corrosive hazardous materials in the U.S. and international hazardous materials (dangerous goods) regulations (IATA) and also are subject to specific packaging, marking, labeling, and shipping paper requirements. “Nonspillable” lead acid batteries are provided an “exception” to the regulations if certain testing and marking requirements are met.

“Dry cell” batteries

“Dry cell” batteries, such as alkaline, nickel cadmium, and carbon zinc are not listed as hazardous materials or dangerous goods in the U.S. and international regulations. However, the batteries must be packed in a manner that prevents the generation of a dangerous quantity of heat and short circuits and packaged in strong outer packaging.

Nickel metal hydride batteries

Nickel metal hydride batteries are listed as Class 9 hazardous materials/dangerous goods (UN3496). When shipped by vessel in quantities over 100 kg they must be shipped as fully-regulated Class 9 hazardous materials/dangerous goods. In all other cases (when shipped via road, rail and air), they may be offered as dry cell batteries in accordance with the applicable Special Provisions.

Handling used batteries

The Batteries Directive 2006/66/EC (consolidated version in 2018): it intends to contribute to the protection, preservation and improvement of the quality of the environment by minimising the negative impact of batteries and accumulators and waste batteries and accumulators.

Properly use and dispose of batteries or they may leak or explode

Lithium batteries may present a fire or chemical burn hazard if mistreated. Do not disassemble, heat above 100°C (212°F) or incinerate. Dispose of used cells promptly.

The food products in this chapter of the catalogue can usually be bought locally. Brands and packaging might vary, as well as the exact (net) volume.

In case the order of an article has to be justified, one or more justification codes (P, M, E, F, A, S) appear on the top of the technical sheet in the catalogue, and in a separate column on the order list. These codes give the reasons why the order of that article has to be justified. A more detailed explanation can be found in the catalogue, under the heading “Article to be justified”.

The request for justification aims at ensuring the programs’ quality, preventing medical risks, and highlighting the existence of programs that the medical or logistics department needs to be aware of.

P PROGRAM

Article reserved for a specific program (e.g.: drugs used in TB programs) or for specific applications (e.g.: HIV testing equipment used for pre-transfusion screening in surgical programs).

M MEDICAL RISK

Article involving a potential medical risk if misused. Its use is reserved for duly trained staff having sufficient knowledge of the medical context which is concerned (e.g.: drugs used in the treatment of angina pectoris).

■ Particular case:

Drug implying a potential risk of abuse and which must be used and/or prescribed by duly trained staff, and safely managed. It may be subject to particular national or international controls (e.g.: narcotic and psychotropic drugs).

E EXPENSIVE

Expensive article of which the choice has to be justified in comparison with cheaper alternatives, considering the cost-effectiveness, the sustainability of the program and the severity of the situation (e.g.: surgical sets for external fixators).

F FOLLOW-UP OR MONITOR

Article newly introduced in the MSF list, for which additional information is necessary in terms of criteria for use, evaluation, consumption, ease of use, follow up of side effects, etc.

A ACKNOWLEDGE

Article that needs to be adapted to each situation after a technical evaluation (e.g.: bungalow containers of which the configuration is specific to each installation).

S SECOND CHOICE

Article must only be used if the first choice is not available or cannot be used in a specific context

Once the order of an article has been justified and agreed by the medical or logistics department for one project, there is no need to justify the following orders of the same article for the same project.

CAUTION: All orders of non-standard medical articles have to be justified

1. VISION

SPINCO is the driver for effective collaboration across the movement to deliver a central source of trusted product information that enables continuous process improvements.

SPINCO is the unit of MSF that was proposed and developed by the logistics and medical departments with the name ITC. The International Technical Coordination was officially recognised at International level in 1994 to maintain consistency in the choice of medical and non-medical articles between MSF sections in order to improve MSF interventions, while taking into account field realities. In 2006 ITC was integrated into MSF International.

The core role is coordinating the expression of the demand of articles (medical and non medical) and ensure it is properly translated for supply whose role is to fulfil that demand. For the last 25 years, SPINCO (former ITC) has been coordinating, producing and dispatching MSF catalogues within the movement which have been developed over all these years to be aligned with the operational needs in the field.

In 2016 UniData has been implemented, which is the unique central article database of MSF that contains all the products created in MSF, avoiding duplication, improving the articles description. Therefore, it provides visibility on the expression of the demand and helps streamlining supply chain processes. UniData details standard, non-standard and non-standard local products, with their descriptions, available for the field and shares article changes with the MSF movement.

SPINCO has been continuously implementing new tools and projects according to operational field priorities. Whilst the focus remains on making the product information available, by integrating UniData with systems and tools across MSF, UniData brings us up to date with the today’s way of working.

2. MISSION

The mission of SPINCO is fourfold:

Social Mission Focus

To contribute towards MSF’s social mission by enabling improvements to field operations through the provision of product information to all layers in the organisation. This enables product quality and visibility for better quality of care, enables assortment management, improves supply chain performance and increases overall interoperability whilst reducing duplications of effort.

Governance

To continuously improve the quality of product information by developing and enforcing information governance rules, definitions and processes. This is done in close cooperation with multiple stakeholders in the domains of Operations, Medical, Logistics and Supply.

Information management

To provide a single source of truth for the product information and ensure that it is available in real time throughout the MSF movement and is accessible together with supporting information via a centralised point.

Co-ordination & Expertise

To provide expertise through product knowledge, services and tools that enable technical integration between the SPINCO systems & tools that manage the information and the MSF systems & tools used in assortment management, supply chain management and other processes for which information managed in SPINCO systems is needed.

The OPD kit is aimed for a general OPD: 10 000 people / 3 months

• Includes the full treatment course for the patient
• The severe cases must be referred: there is no Oxygen, no transfusion
• Contains small size sterilization equipment: 39 litres autoclave and few injectable medicines

It is composed of 3 parts

• Medical equipment
• Medicines and renewable medical supplies
• Optional complementary part with observation beds

The support activities Sterilisation and Pharmacy are mandatory in one of the 6 main activity focal points.

Emergency room for 300 patients and 4 beds/boxes:

• General emergencies: medical, surgical, gynaecological/obstetric, paediatric
• The patient receives only the first dose of treatment (it is not an OPD = outpatient department)
• The patient is referred rapidly to one of the hospital wards
• A medical doctor trained in the management of complicated emergencies must be present.

It is composed of 2 parts

• Medical equipment
• Medicines and renewable medical supplies

The support activities Sterilisation and Pharmacy are mandatory in one of the 6 main activity focal points.

The Intensive Care Kit (ICU kit) is intended to be used as part of the hospital kit for various types of critical care services (HDU, ICU ..).

The ICU part can only be ordered together with:

• the OPD part
• the ward part (minimum 1 ward)
• the operating theatre part (minimum 1 operating room)
• the 4 mandatory support activities modules:
• laboratory
• sterilization
• pharmacy
• divers modules

The kit contains equipment necessary for a mixed critical care unit (4 beds).

The ICU part can not be ordered if you are not located in a fully equipped hospital with skilled ICU staff, that can ensure a presence 24 hours a day.

It is composed of 2 parts

• Medical equipment for 4 beds
• Medicines and renewable medical supplies

Diagnostic equipment and supplies are included in the two parts

Stationary materials and other miscellaneous parts are included in the renewable supplies.

The kit is organised in different modules with a basic configuration (only mandatory modules) and an advanced configuration (some or all optional modules). This is intended to give flexibility and to be better adapted to each and every field.

Optional modules that can be added as needed depending on the type, level of care, skills and structure in which they are used.

Remarks

Although specialised activities were taken into account, purely specialised services such as burn ICUs, paediatric ICUs and neonatal ICUs should use an order with a medical standard list as some items and quantities might not be suitable.

The kit contains internationally controlled substances (= psychotropic and narcotic drugs). It might be necessary to get an Import Licence from receiving National Authorities for these drugs.

Choice : it is mandatory to order one the two proposed choices

In part medical equipment it is mandatory to order either the English version, either the French version for the syringe pump “Agilia SP MC” and the defibrillator "AED Pro", both presented as choice.

All options, indicated as "OPTION" (column "Tot Qty"), must be ordered in addition.

Essential for harmonizing supplies on the field, the standardization process consists in clearly defining the most suitable equipment and supplies for a given situation, according to the following criteria:

• observance of the policies defined by the MSF medical and logistic directors
• quality and efficiency within the framework of MSF programmes
• easy maintenance and supply of spare parts/consumables
• “international agreement”: validation by all MSF sections
• purchasable by at least one European Supply Centre (ESC)

Therefore, a standard article has gone through a standardization process, supervised by SPINCO and is the best choice for field use.

1. OPEN / CLOSED ARTICLES

Normally, articles are OPEN => “open articles” refer to a GENERIC PRODUCT, which corresponds to a set of technical specifications fulfilling a given function.

This means that all products with the technical specifications as described in the technical sheet are liable to be purchased regardless of their brand. Each MSF section may choose the product to be supplied as long as the required technical specifications are met.

E.g.: Several manufacturers make an external hard disk which meets the technical specifications of the article

EXTERNAL DRIVE, 320 Gb (ADAPMEMOEG3I)

Occasionally , some articles are CLOSED => “closed articles” refer to a SPECIFIC PRODUCT of a certain model and brand.

This means that the article is a particular model of a particular brand, and all MSF centres must supply exactly the same model of the same brand. Closed articles have been selected due to quality and/or safety reasons by international working groups, including technicians of different sections. They are mainly (electrical) apparatuses where maintenance and supply of spare-parts, accessories and consumables are mandatory, and adapted to specific MSF conditions (dust, heat etc.).

E.g.: The article “CONCENTRATOR O2 (DeVilbiss 525KS)” refers only to the 525KS model manufactured by DeVilbiss.

2. KITS AND MODULES

Although every medical response should be specifically planned based on information provided by the exploratory mission and reliable data, a kit containing essential items is nonetheless useful for an emergency. Intended for emergency contexts, the kits are ready to be delivered within a very short timeframe.

A module is a set of articles which is either a part of a kit or the optional complement to a kit.

Frequently, for reasons related to stability, taste or solubility, the base form of a drug is administered in an altered form, such as an ester or salt. This modified form usually has a different molecular weight.

For example, caffeine citrate:

There are therefore two ways to express the active ingredient content of a medicine: either based on the salts contained in the formulation (e.g., 20 mg of caffeine citrate in this case) or based on the base equivalent that contributes to the pharmacological activity of the medicine (e.g., 10 mg of caffeine base).

In English-speaking countries, the content is typically expressed as salt, while in French-speaking countries, it is usually expressed as base. Unfortunately, there is no international standard for this, leading to frequent confusion between the two methods. As a result, it is not unusual for drugs labelled as bases to be used in protocols that express them as salts, and vice versa.

For salts where the non-active part is relatively small compared to the active part, these confusions often result in negligible errors. However, with small active molecules combined with heavy salts (such as phosphates, sulphates, carbonates, citrates, fumarates, etc.), the non-active part can constitute more than half of the molecular weight. In such case, confusions can lead to underdosage (resulting in ineffective treatment or a risk of resistance) or overdosage (increasing the risk of adverse effects). Examples of such products include caffeine citrate solution for injection and chloroquine phosphate tablets.

INTERNATIONAL NARCOTICS CONTROL BOARD (INCB)

The International Narcotics Control Board (INCB) is an independent, quasi-judicial expert body established by the Single Convention on Narcotic Drugs of 1961 through the merging two bodies:

• the Permanent Central Narcotics Board, established by the 1925 International Opium Convention, and
• the Drug Supervisory Body, established by the 1931 Convention for Limiting the Manufacture and Regulating the Distribution of Narcotic Drugs.

The INCB consist of 13 members, elected by the Economic and Social Council for a five-years term, with eligibility for re-election. Ten of these members are elected from a list of candidates nominated by governments, while the remaining three are selected from a list of candidates nominated by the World Health Organisation (WHO), based on their medical, pharmacological, or pharmaceutical experience. INCB members serve in an impartial, personal capacity and are independent of their respective governments.

The production and distribution of controlled substances must be licensed and supervised. Governments are required to provide the INCB with estimates and statistical reports on the drug quantities required, manufactured and used, as well as on quantities seized by police and customs. Each year, the INCB publishes data on the illicit trafficking of drugs under international control.

INTERNATIONAL CLASSIFICATION OF NARCOTIC AND PSYCHOTROPIC DRUGS

Approximatively 250 substances are listed in the schedules annexed to the Single Convention on Narcotic Drugs (New York, 1961, amended in 1972), the Convention on Psychotropic Substances (Vienna, 1971), and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (including precursor control) (Vienna, 1988). The aim of this list is to regulate and restrict the use of these drugs based on their therapeutic value, potential for abuse, health risks, and to prevent the diversion of precursor chemicals to illegal drug manufacturers.

Narcotic drugs

Narcotic drugs are classified and placed under international control by the United Nations Single Convention on Narcotic Drugs of 1961, as amended in 1972. This convention limits 'exclusively to medical and scientific purposes the production, manufacture, export, import, distribution of, trade in, use and possession of drugs' (art. 4c).

The Yellow List contains the complete list of narcotic drugs under international control according to 1961 Convention.

The Yellow List is available at: https://www.incb.org/incb/en/narcotic-drugs/Yellowlist/yellow-list.html

Narcotic drugs are classified in four schedules:

To identify the schedule of narcotic drugs and their MSF attribute (Narcotic 1, 2, 3, 4), consult your European Supply Centre website (see below).

Psychotropic drugs

Psychotropic substances are regulated under international control by the 1971 United Nations Convention on Psychotropic Substances. The purpose of this Convention is are again to limit the use of these substances to medical and scientific purposes (arts. 5 and 7).

The Green list contains the list of psychotropic substances under international control according to the 1971 Convention.

The Green List is available at: https://www.incb.org/incb/en/psychotropics/green-list.html

Psychotropic drugs are classified in four schedules:

To identify the schedule of psychotropics drugs and their MSF attribute (Psychotropic 1, 2, 3, 4), consult the website of your European Supply Centre (see below).

Precursors

Precursors are chemicals frequently used in the illicit manufacture of narcotic drugs and psychotropic substances and are subject to international control under the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988.

The Red List contains the list of precursors under the 1988 Convention.

The Red List is available at: https://www.incb.org/incb/en/precursors/Red_Forms/red-list.html

Precursors are classified in two tables with the MSF attribute "DP" (Drug Precursor).

To identify the table of precursors and their MSF attribute (Drug Precursor 1, 2), consult the website of your European Supply Centre (see below).

INTERNATIONAL ORDER OF NARCOTIC AND PSYCHOTROPIC DRUGS

When exporting or importing narcotic or psychotropic drugs, the legislation of all countries involved must be considered.

The exporter typically needs to present an import permit from the destination country to obtain an export permit for these substances.

If importing for re-export (ImpEx) via a third country (e.g. via Kenya for Somalia), the regulations of the third country must also be followed, or the transit regime should be selected.

In some countries, additional controls may apply if these products are considered chemical weapons by the Office of National Security (beyond the oversight of the National Drug Regulatory Authority).

Importing country

Verify the regulations custom clearance procedures with the Ministry of Health, National Medicines Regulatory Authorities (NMRA), etc.

Some countries prohibit the import of narcotics by humanitarian agencies or allow it only in cases of national supply chain disruptions (exceptional import requests).

Import permit for narcotic and psychotropic drugs

An import permit, usually issued by the Department of Narcotics of the Ministry of Health or NMRA, must include at least:

• Permit number
• Date of issue
• Expiry date of this permit: should be at least 3-4 months, date by which importation must take place. Note: in some countries, extension may be possible.
• Name and address of the importer: MSF name only (instead of the medical coordinator) to avoid delays from changes in coordinator. Otherwise the MSF procurement centre has to apply for a new address to the concerned European MoH in case the coordinator changes.
• Name and address of the exporter: verify with your procurement centre or medical department.
• Details of the product: number of units (ampoules, vials, capsules, tablets, oral drops, oral solution, patches or rectal tubes), in letters and numbers, with precise volume, dose, total active ingredient content (in mg or g). Example: one hundred (100) ampoules of fentanyl, 0.05 mg/ml, 2 ml, totalling 10 mg of active ingredient). Ensure proper conversion if the product is a salt (e.g. morphine HCl) as some countries request the base content of the drugs. Example: 40 vials of morphine hydrochloride 10 mg/ml, 1 ml contain 400 mg of morphine hydrochloride, but only 40 x 7.6 mg = 304 mg of morphine base.
• Name and signature of the authority issuing the permit: preferably on official letterhead.

Remarks

• Carefully review import permits for errors before sending, as changes cannot be made after issuance.
• Orders should be placed per full pack quantity as specified on the permit. You can import less than what is specified on the permits but not more.
• Some countries require additional information (e.g. name and address of the manufacturer) or documentation (e.g. Certificate of Analysis, cGMP, Proforma INV, etc.) as this is important for the procurement centre re-order process (if stock (picking) reservation is required for example).
• In some countries, a general import permit must be obtained before applying for a Special Import Permit (regulated items) (e.g. Ethiopia and Nigeria)
• The scanned copy of the import permit can be sent to the procurement centre to begin the export permit process, followed by the hard copy. Some countries require the return of the hard copy after after obtaining the export permit (e.g. Uganda).
• The MSF procurement centre will use the import permit to apply for the export permit to their concerned MoH. The import permit can only be used once for this application.
• Review the website of your procurement centre for specific information on which drugs require an export licence, grouping drugs on a single import permit, number of orders per mission (usually one order for the whole mission instead of one per projec,t and preferably annual due to the time to obtain the import/export permits), how to send the import permit.
• The import permit must be sent direct to your procurement centre (and not the NMRA)

Exporting country (where the order is placed)

Check the instructions on the website of your procurement centre:

• MSF Supply: https://msfsupply.atlassian.net/wiki/spaces/SC/pages/1549598721/Narcotics+and+psychotropic+drugs
• MSF Logistique: https://msfintl.sharepoint.com/sites/SP-BDX-msflog-op-general-info/products-information/chemical-precursors
• https://msfintl.sharepoint.com/sites/SP-BDX-msflog-op-general-info/products-information/psychotropic-narcotic-classified-products

Exceptional cases

In certain situations (e.g., civil war, guerrilla-controlled areas), if the competent authority is no longer operational or not a member of the INCB (e.g. South Sudan), or if the local competent authority is under other authority (e.g., KMCA-Kurdistan Medical Control Agency- for Iraq is under Baghadi authorities) and cannot issue import permits, the responsible pharmacist at each European Supply Centre may negotiate with its ministry and the International Narcotic Control Board in Vienna. This may lead to obtaining a permit to export small quantities of controlled narcotic or psychotropic drugs via WHO Emergency Authorisation Procedure. This procedure is also possible in emergency situations (e.g., natural disasters). A written request signed by the medical director of the MSF section should be sent to the pharmacist responsible for controlled drugs at the MSF procurement centre. The medical coordinator must promptly acknowledge receipt, which is then used for reconciliation with the NMRA associated with the supply centre.

Transportation of narcotic and psychotropic drugs to missions

Transport will generally be by air, as the import permit is typically valid for three months (though it is often longer). The drugs must arrive in the country before the permit expires.

CONTROLLED SUBSTANCES IN THE KITS

A specific module is created for regulated drugs (code ending with "C") for each kit. However, this module is not automatically supplied when the kit is ordered. These regulated products will not be included in the kit or module and must be ordered separately. An import permit for each of these drugs must be sent to the procurement centre.

Note: this applies only to medical items regulated at the supply centre level (those requiring an export permit in the EU). If the product is regulated (narcotic, psychotropic, or precursor) only in the destination country, these items will not be automatically separated by module in the kit. It is the mission's responsibility to screen the kit contents using the detailed Medical Kit List detailed, available on the MSF Catalogues website.

STORAGE AND HANDLING OF REGULATED PRODUCTS IN THE FIELD

It is essential to adhere to the list of regulated drugs and legal requirements in the country, where MSF operates, as we are not exempt from national law. We work with national staff and MSF pharmacies may be subject to inspection by health authorities for evaluation.

In general

• Identify regulated drugs: confirm what is considered a “regulated drug” by the national authorities, as the list may vary from country to country.
• Designate responsible personnel: appoint 2 or 3 people responsible for the movement and tracking of regulated products.
• Maintain written records: all pharmacies should have a written list of regulated drugs.
• Storage requirements: regulated drugs must be stored securely (under lock and key) in accordance with the country's regulations, under the responsibility of the designated personnel. Drugs included in a kit should be identified by the kit name.
• Ensure proper handling: double-check the different steps of handling (reception, packing, authorisation, dispatch, etc.).
• Follow FEFO principle: The "First Expired First Out (FEFO) principle applies to regulated drugs. Ensure expiry dates are regularly checked, especially for drugs in kits.
• Track and report movements: record the movement of drugs in a separate register. National health authorities may require regular written reports of movements and consumption. If required, ensure that stock movements are officially documented.

The deterioration of medicines depends on various factors, including the product type, manufacturing process, quality of raw material, excipients, etc. Storage conditions also play a significant role. The shelf-life of a product is determined based on an average rate of deterioration under standard conditions of temperature, humidity, and light, as specified by the International Conference on Harmonisation (ICH) for the climatic zone where the medicine will be marketed. The expiry date is set to ensure that, under these conditions, the therapeutic effectiveness remains unchanged (at least 90% of the active ingredients must be present) and that there is no significant increase in toxicity.

Quality is defined as “the suitability of a pharmaceutical product for its intended use”. Each medicine intended for patient use must meet acceptable quality standards, including identity, purity, safety, and efficacy.

If a medicine fails to meet quality standards, the consequences can include:

• lack of therapeutic effect, potentially leading to prolonged illness or death,
• toxic or adverse reactions,
• wastage of financial resources, and
• loss of patient confidence

The quality of pharmaceutical products is affected by raw materials, the manufacturing process, packaging, transport and storage conditions. These influences may accumulate over time.

Stability is defined as “the extent to which a product retains, within specified limits, and throughout its period of storage and use (i.e., its shelf-life), the same properties and characteristics as it had at the time of manufacture” (USP 37).

EXPIRY DATE

Even when stored under proper conditions, medicines naturally deteriorate over time due to various processes.

In many countries, manufacturers are legally required to study the stability of their products under standardised and exaggerated environmental conditions. These studies help manufacturer select the optimal formulation, packaging, storage conditions, and ultimately determine an expiry date for each dosage form in its packaging.

The manufacturer’s expiry date refers to the expiry date of the unopened container.

The International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use guidance document defines shelf-life as: “The period of time during which a pharmaceutical product is expected to remain within the approved shelf-life specification, provided it is stored under the conditions defined on the container label.”

Most pharmaceutical products have a shelf-life of 3 to 5 years. Products containing less stable substances are guaranteed for only 1 or 2 years.

Practical definition of shelf-life: the time between the date of manufacture and the expiry date.

For products sent to the field, the remaining shelf-life should be at least 1/3 of the total shelf-life. This means that 1/3 of the shelf-life should remain at the time the product is released from stock (Note: transport and handling may take additional time). For medical kits, which often only have 6 months of remaining shelf-life, they should only be ordered for emergency situations and not for EPREP stock.

The expiry date is clearly indicated on both primary (immediate) packaging and secondary packaging:

The UK MHRA advices pharmaceutical manufacturers that the term ‘expiry date’ means the product should not be used after the end of the month stated. For example, an expiry date of 12/2025 means the product should not be used after 31 December 2025.

On the other hand, the UK Royal Pharmaceutical Society (RPS) clarifies that when a product is labelled ‘Use by’ or ‘Use before’, it means the product should be used before the end of the previous month. For example, ‘Use by 06/2025’ means the product should not be used after 31 May 2025.

Caution

It is important not to confuse the date of manufacture with the expiry date (“Exp. Date”).

SHELF-LIFE - IN-USE SHELF-LIFE

Once a multi-dose drug container is opened, the exposure of the drug to environmental factor can shorten its shelf-life. Repeated opening and closing of the container may increase the risk of microbiological contamination and/or physico-chemical degradation. This risk is particularly high in bulk packaging and for certain medicines, such as anti-tuberculosis medicines, which are sensitive to temperature and humidity.

Some oral or injectable multi-dose products are provided in powder form tat needs to be reconstituted before use. After reconstitution, these products may undergo significant hydrolysis and thus have a limited shelf-life. Some may require refrigeration. For non-sterile medicines, always consult the manufacturer's leaflet for information on the in-use shelf-life. If such information is provided, follow the manufacturer’s guidance. If not, refer to the table below. Always record the date the product was opened and the updated expiry date on the medicine label or, if there is insufficient space, on the outer packaging.

Notes:

• Sterile products: any remaining content should be discarded immediately after the first use.
• Ointments: these are semi-solid, greasy preparations intended for application to the skin or mucous membranes.
• Creams: these are similar to ointments but contain an aqueous phase, making them more susceptible to microbiological contamination.
• Use of jars: a 100 g jar is intended for individual use. A 500 g jar can be used between multiple patients (e.g. in an hospital ward), but carres an increased risk of contamination.

BASIC STORAGE GUIDELINES

Proper storage is essential to maintaining the effectiveness and safety of medicines, as they can be sensitive to environment factors such as light (especially sunlight), oxygen, moisture, and extreme temperatures.

MSF follows manufacturer storage recommendations in alignment with WHO GDP Guidelines and MSF transport policy

• Keep medications in their original containers and outer packaging to protect them from sunlight.clearly
• Ensure the container is tightly closed to prevent exposure to air and moisture.
• Avoid opening containers before use.
• Do not remove desiccant packets (e.g. silica gel) from the packaging, as they help control moisture levels.
• Always check and respect the expiry dates - do not cover them with labels or writings.
• Store medicines according to the manufacturer's instructions.
• Follow the FEFO (First Expired, First Out) policy to manage stock.
• Organise cartons properly, ensuring that arrows are pointing upward and that identification labels, expiry dates, and manufacturing dates are visible.

Protecting products from sunlight:

• Cover windows or use curtains to block direct sunlight exposure.
• Store products in their original packaging and in cartons.
• Avoid storing or packaging products in direct sunlight.
• Use opaque plastic or dark glass bottles for products that are specifically sensitive to light.
• Maintain trees around the facility to provide natural shade, but regularly check for any branches that could potentially damage the facility.

Temperature storage for medical consumables:

• Store frozen: products that require storage at temperatures of -20ºC, such as certain vaccines, should be transported in a cold chain and stored frozen, typically for longer-term storage at higher-level facilities.
• Store refrigerated: store products at a temperature between 2°C and 8°C. This range is suitable for products that are heat sensitive but should not be frozen, such as vaccines. (For further information see Vaccines family).
• Keep cool: store products between 8°C and 15°C. This is for products that need to be kept cool but are not as temperature-sensitive as those requiring refrigeration.
• Store at room temperature: store products at a temperature between 15°C and 25°C. This is the standard temperature range for most of medical products.
• Store at ambient temperature: while not widely used, this term refers to normal storage conditions. Ambient temperatures typically means “room temperature”, ranging from 15°C to 25°C or up to 30°C, depending on local climate conditions. It implies storage in a dry, clean, and well-ventilated area.

Measures to reduce effects of humidity:

• Ventilation: ensure proper airflow by opening windows (with screens and bars) or using air vents. Store products on pallets and maintain space between pallets and walls.
• Secure lids: make sure all container lids are securely closed to prevent moisture from entering.
• Air circulation: use fans to improve airflow and reduce humidity build-up.
• Air conditioning: use air conditioning to control temperature and humidity levels.

Monitoring temperature and humidity in the medical storage area

• Manual monitoring: temperature and humidity should be manually checked twice a day, including on weekends
• Electronic monitoring instruments: use electronic devices for continuous monitoring that can record and track temperature and humidity over time, including minimum and maximum readings. To be monitored twice daily as well.
• Importance of manual checking: while remote monitoring systems are valuable, they should not replace the twice daily manual checks.

DETERIORATION OF MEDICINES

Medicines can deteriorate even if their expiry date has not been reached, particularly if they have been stored under conditions (temperature, humidity, and light) that differ from the conditions used during stability testing. Excessive or accelerated deterioration can also occur due to initial quality defects, such as manufacturing issues. Therefore, it is important to understand the normal appearance and characteristics of each medicine (colour, odour, solubility, consistency) in order to detect any signs of deterioration.

Some forms of deterioration may not show visible changes, but physical changes should be closely monitored. Any medicine showing signs of deterioration should be discarded, regardless of the expiry date. If any doubt, contact the pharmacist for advice.

Signs of deterioration:

• For all products: broken or ripped packaging, missing, incomplete or illegible labels.
• Liquids: discolouration, cloudiness (turbidity), sediment or unsuspended agglomerates in solutions, broken seal on bottles, cracks in ampoules, bottles or vials, moisture in packaging.
• Light-sensitive products: torn or damaged packaging
• Tablets: discolouration, crumbled tablets, tablets missing from blister packs, sticky tablets (especially coated tablets), unusual smells..
• Capsules: discolouration, sticky, crushed capsules
• Injectables: liquid that does not return to suspension after shaking.
• Tubes: sticky tubes, leaking contents, perforations or holes in the tube.
• Sterile products: torn or ripped packing; missing parts; broken or bent parts, moisture inside packaging; stained packaging.
• Foil packaging: perforation in packaging.
• Suppositories, pessaries, creams and ointments: melting, separation of phases.

Using expired or deteriorated drugs

MSF DOES NOT recommend the use of expired or damaged medicines due to the significant risk for the patient safety.

DESTRUCTION OF EXPIRED AND/OR DETERIORATED DRUGS

Check local regulations regarding medical waste management and environmental protection before implementing a disposal method.

Proper disposal is critical, as incorrect disposal can lead to serious negative consequences, including:

• water contamination
• the diversion and illegal resale of expired or inactive medicines
• toxic pollutants being released into the air due to improper incineration.

Particular attention must be given to the disposal of certain categories of pharmaceuticals, including controlled substances (e.g., narcotics and psychotropic drugs), anti-infective drugs, cytotoxic anti-cancer drugs, toxic drugs, aerosols, antiseptics, and disinfectants.

Normally, MSF should obtain authorisation for destruction from the relevant local authorities and ensure that the destruction method adheres to both WHO and MSF guidelines, as these may differ from local guidelines (if any). In specific cases, such as batch recalls, MSF must also obtain a certificate of destruction.

INTRODUCTION

The WHO defines packaging as a collection of various components (e.g. bottle, vial, closure, cap, ampoule, blister) which surround the pharmaceutical product from production until its use¹. The US FDA defines the container closure system (CCS) as the combination of packaging components that work together to contain and protect the dosage form. This includes both primary and secondary packaging components, with the latter intended to provide additional protection to the drug product².

Any proposed packaging system must be proven to be suitable for its intended use: it should adequately protect the dosage form (against light, moisture, oxygen, contaminants, etc.); it should be compatible with the dosage form (without adsorption of the active pharmaceutical ingredient, etc.); it should be made from materials considered safe for use with both the dosage form and its route of administration (without migration of potential toxic substances); and it should function as intended (performance features).

Child-resistant closures are designed to make it difficult for young children to open drug packaging while still allowing easy access for adults. The use of child-resistant packaging has been shown to effectively reduce child mortality due to intoxication from oral prescription drugs. The three most common common types of reclosable child-resistant closures are “press–turn”, “squeeze–turn” and a combination lock (WHO TRS 902).

Tamper-evident packaging refers to a system where access is impossible without visible destruction of the seal or some part of the packaging (USP 659) or one that “provides visible evidence to consumers that tampering has occurred” (WHO 902). Examples of packaging technologies capable of meeting the TRP requirements are given in “FDA Compliance Policy Guide, 7132a. 17, CPG Sec. 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products”.

¹ WHO, TRS 902 Annex 9

² USFDA, Container Closure Systems for Packaging Human Drugs and Biologics

CONTAINER CLOSURE SYSTEMS FOR SPECIFIC PHARMACEUTICAL FORMS

CONTAINER CLOSURE SYSTEMS FOR PARENTERAL PREPARATIONS (DINJ and DINF)

Parenteral drug products are sterile preparations, typically liquids in the form of solutions, emulsions, suspensions, or dry solids that must be reconstituted with an appropriate vehicle to obtain a solution or suspension. They are classified as small-volume parenterals (SVPs) if the volume is 100 ml, or less, and as large-volume parenterals (LVPs) if the volume exceeds 100 ml.

SVPs (DINJ family) may be packaged in disposable cartridges, disposable syringes, vials, ampoule, flexible bags, or semi-rigid bottles. Only single-ended ampoules are accepted by MSF.

• Cartridges, syringes, vials, and ampoules are usually made of Type I or II glass or polypropylene. Specific glass types for each pharmaceutical form can be found in the European Pharmacopoeia (EP), British Pharmacopoeia (BP), or United States Pharmacopoeia (USP).
• Stoppers and septa used in cartridges, syringes, and vials are typically made from elastomeric materials. Closures for injectable preparations must meet the Type I (for aqueous preparations) or Type II (for non-aqueous preparations) test limits defined in the EP or USP.
• Caps or over seals are used to secure the rubber closure to the container to maintain the integrity of the seal under normal conditions of transport, handling, and storage during the product's shelf-life. These caps are usually made of aluminium may include a plastic top for easier opening. Caps also provide evidence of tampering.

LVPs (DINF family) may be packaged in flexible bags (with or without PVC), semi-rigid bottles, or a glass bottles. MSF's first choice is PVC-free flexible bags or semi-rigid bottles, as those containing are no longer accepted. The containers must have a site suitable for the attachment of an infusion set and a site that allows the administration of drugs.

Flexible bags are typically made of multi-layer plastic.

• Cyclo-olefins offer an alternative to PVC or glass; they are flexible and have low permeability.
• Flexible bag ports (for input of medication and output for administration) are made from plastic and/or elastomeric materials. These bags usually include a hanging part to withstand tension during use.
• Depending on the plastic used, IV fluid bags may have a protective pouch/overwrap that protects against solvent loss (which can lead to increased concentration), oxygen ingress, and dust. The over pouch is made from material with low permeability to water and gases.

Semi-rigid plastic bottles are typically made using Blow-Fill-Seal (BFS) technology and come with a sealed top that can be fitted with various types of closures. Some manufacturers offer open-neck bottles fitted with rubber stoppers and a flip-off caps.

• BFS bottles with a nipple head are not appropriate, as the base of the nipple head is fragile and the small cap does not provide adequate protection, leading to potential fatigue points and micro-holes during transport. Additionally, they lack an injection or administration site, requiring the top of the nipple to be pierced by the IV set or the needle. If alternative is available, experts recommend using larger caps for better head protection.
• Euro head caps are acceptable, but present some risks, including contamination of the top before welding if not done in an aseptic environment, and the potential for the space between the bottle top and cap to remain unsterilised due to insufficient penetration of water vapour.
• Newer generation caps have two access ports for the IV set and admixture, typically protected by an aluminium seal or a plastic cover (Twincap^®, Duocap^®).

CONTAINER CLOSURE SYSTEMS FOR OPHTHALMIC PRODUCTS (DEXO)

Ophthalmic preparations are sterile products, avaiable in liquid, semi-solid, or solid forms, specifically designed for application to the eye. These preparartion can be categorized into eye drops, eye lotions, semi-solid eye preparations, and ophthalmic inserts.

Liquid preparations for ophthalmologic use are typically packaged in sterilised single-dose (often preservative-free) or multi-dose containers. Multi-dose products are most commonly packaged in polyethylene (PE) or polypropylene (PP) bottle with an integrated dropper on the neck, sometimes referred to as "droptainers". For some eye drops, glass containers may be used when there are stability or compatibility concerns with flexible plastics. The container must be tamper-evident and contain a maximum of 15 ml of the preparation. Single-dose containers are generally made from . PP manufactured using the Blow-Fill-Seal (BFS) technique. Some preparations may be indicated for both ophthalmic or otic use (e.g., DEXTCIPR1D- : a preparation for eye and/or ear).

Semi-solid eye preparations are packaged in small, collapsible sterilised tubes, with or without an ophthalmic cannula or tip. These tubes are typically made from metal, though ophthalmic ointments that react with metal may be packaged in tubes with an epoxy or vinyl plastic coating inside. The packaging must be tamper-evident and contains no more than 5 g of the preparation³.

³ USFDA, Container Closure Systems for Packaging Human Drugs and Biologics.

CONTAINERS FOR TOPICAL PRODUCTS⁴ (DEXT)

Topical dosage forms include aerosols, creams, emulsions, gels, lotions, ointments, pastes, powders, solutions, and suspensions. These forms are typically intended for local (non-systemic) effects and are usually applied to the skin or oral mucosa. Topical products also include ceratin nasal and ear preparations, as well as vaginal and rectal pharmaceuticals.

Semi-solid or liquid preparations are commonly packaged in multi-dose containers, such as jars or collapsible tubes.

• Flexible (collapsible) tubes are usually made from metal (or metal-lined), LDPE, or laminated materials. These tubes are classified as closed-ended or open-ended. In closed-ended tubes, the product does not come into contact with the cap during storage.
• Jars are usually made of polypropylene and have a screw cap. The same type of cap liners and inner seals are sometimes used for solid oral dosage forms.
• Nasal, otic, vaginal, and rectal preparations should be packaged in containers suitable for their appropriate administration at the application site, or should be supplied with an appropriate applicator.

The closures of these containers should be designed to minimise the risk of microbial contamination and should be tamper-evident.

Liquid ear preparations⁵ are supplied in multi-dose containers made from glass or suitable plastics. These containers often have an integrated dropper or a screw cap from appropriate materials, which may incorporate a rubber dropper or plastic teat, sometimes provided separately.

Vaginal and rectal products are usually packaged in aluminium/aluminium strips or blisters, or occasionally in tubes (e.g., vaginal gel).

⁴ WHO, TRS 902 Annex 9 ; Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products, Sarfaraz K Niazi, CRC Press, 2009
⁵ Ph Eur monograph 0652, Ear Preparations

CONTAINERS FOR ORAL MEDICINES (DORA)

Liquid oral pharmaceutical products⁶, such as solutions, syrups, or suspensions, require protection from solvent loss, microbial contamination, and sometimes Exposure to light or reactive gases (e.g., oxygen). These liquid dosage forms can be supplied in either multiple-dose (bottles) or single-dose (sachets) containers.

• Bottles are usually made of glass or plastic (e.g., PET, HDPE), often featuring a screw cap (made of aluminium or polypropylene) with a liner, and may include a tamper-resistant seal or an overcap welded to the bottle.
• Each dose from a multi-dose container is administered using a device suited for measuring the prescribed volume, such as a measuring cup, dosing spoon (for volumes of 5ml or more), oral syringe (for other volumes), or a dropper.
• Many of the associated components are graduated for dose administration. Graduations should be legible and indelible.
• Pouches may be made of a single-layer plastic or laminated material.

Solid Oral dosage forms (e.g. tablets and capsules) and powders for reconstitution should generally be protected from the potential adverse effects of water vapour (moisture). Typical container closure systems are bulk containers, strips, blister packs and sachets.

Bulk containers are plastic or glass bottles with a screw or snap closure.

• Glass containers are made of type III glass. Plastic containers are most often made of HDPE, PP or PET. The primary packaging may be a LDPE bag, which is then placed in HDPE/PP bottles and provides additional protection.
• A typical closure consists of a cap (often made of PP), often with a sealed part. The seal is a piece of material that sits between the cap and the bottle. Different liner materials can be used to provide a moisture barriers, chemical resistance, or preventing leakage. Another benefit is tamper evidence; once the sealed part has been removed, it cannot be reapplied to the container.
• A filler material can be added to the container to fill the empty spaces and prevent the tablets from breaking during transport. Fillers can be made of cotton, rayon or polyester.
• Desiccant is used to reduce the amount of moisture in the head space of the bottle, and to protect gelatin capsules or moisture sensitive products/substances. The shape and size of the desiccant should be clearly distinguishable from the shape of the medicine to prevent accidental consumption. The desiccant is usually packed in a small HDPE canister or sachet which should be placed on top of the tablets.
• A bulk container should not contain more than 1000 tablets.

Strips are multi-dose containers consisting of two layers of aluminium, usually provided with perforations, suitable for containing single doses of solid or semi-solid preparations⁷.

Blisters are multi-dose containers consisting of a moulded film insert that contains the product and a cover, which is the material that seals the blister.

For the film blister, different types of materials and many combinations - offering different degrees of protection from water vapour, gas and light - are available on the market ⁸. However, due to the lack of barrier properties of PVC film, multi-layer PVC-based films are often used when better moisture protection is required, e.g. PVC coated with PVDC (polyvinylidene chloride), PVC laminated with PCTFE (polychlorotrifluoroethylene, or Aclar®), triplex laminates made of PVC/PE/PCTFE, etc.

The lid stock is sealed to the moulded blister. Its material is usually a laminate that includes a barrier layer (e.g., aluminium foil).

Sachets are adequate packaging for oral powders in single-dose preparations. Each dose is enclosed in an individual sachet preferably made of laminated aluminium foil, the edges of which are sealed by heat or adhesive.

⁶ USFDA, Container Closure Systems for Packaging Human Drugs and Biologics; USP <659> Packaging and storage requirements

⁷ WHO, TRS 902 Annex 9

⁸ USP <1146> Packaging practice—repackaging a single solid oral drug product into a unit-dose container

PHARMACEUTICAL PRODUCTS FOR INHALATION (DORA)

Preparations for inhalation are intended to be administered as vapours or aerosols into the lung to obtain a local or systemic effect. These products may be supplied in either multi-dose or single-dose containers ⁹.

Inhalation pharmaceuticals include:

• Aerosols in pressurised metered-dose devices: The preparation is released from the container as an aerosol upon activation of an appropriate valve.
• Liquid preparations for inhalation: Administered using nebulizers, these are usually packaged in a PP (polypropylene) single-dose containers.
• Inhalation powders: Delivered by dry powder inhalers, which are loaded with pre-dispensed powders in capsules or other suitable dosage forms, or with a powder reservoir and a metering mechanism
• Nasal sprays: designaded for nasal administration

⁹ Ph Eur monograph 0671: Preparations for inhalation; USFDA, Container Closure Systems for Packaging Human Drugs and Biologics.

A code allows ordering an article without any ambiguity on what is requested and helps to streamline the supply chain. MSF has created an international codification based on the article’s English label, and is significant so that codes itself “tells” what is being ordered.

With the central masterdata system, UniData, both types of articles, standard and non-standard are codified with the following set of codification rules. An MSF code is composed of min 11 and max 13 alphanumerical characters and structured in 4 subdivisions.

In the order tools, the code of the article is followed by the attribute indicating the standardization level.

• STD = standard article ( = validated by the 5 operational centres = OC’s)
• NST = non-standard article (= not validated by the 5 OC’s but used by one or few operational centres)
• NSL = non-standard local article ( = validated by one or few OC’s and purchased locally due to country constraints).

The MSF catalogues include only STD articles.

1. THE GROUP SUBDIVISION

The GROUP is defined by 1 character which identifies a functional category. Some groups are exclusively medical and others exclusively logistic, while group K (kits) contains both categories.

9 groups have been defined:

2. THE FAMILY SUBDIVISION

The FAMILY is defined by 3 characters which identify a speciality within a group. A family is either exclusively medical, exclusively logistical or exclusively library, except the leaflets family (LEAF) which is both: medical and logistical.

Medical families

Logistical families

Field Library families

3. THE ROOT SUBDIVISION

The ROOT is defined by 4 characters and is built from the article’s English label or description.

E.g.: CLOXACILLIN, 250 mg, caps => CLOX

A same root can belong to several families:

E.g.: CLOXACILLIN, 250 mg, caps => DORA CLOX

CLOXACILLIN, 500 mg, powder, vial => DINJ CLOX

NB: When an article’s label starts with the letter “Z”, the first character of its root will be “Y” to prevent any confusion with the “local code”.

Electro-mechanical equipment and their accessories, consumables and spare-parts are identified with a root of 3 letters followed by a letter E for equipment, A for accessory, C for consumable, S for spare-part and T for test/control.

See introduction on Electro mechanical medical devices in Medical Catalogue Volume 3

4. THE SPECIFICATION SUBDIVISION

The SPECIFICATION is defined by 3 to 5 characters and allows the differentiation of two similar articles. These specifications are often significant and follow the rules set-up for that specific root.

For some groups of articles MSF chooses to work with a manufacturer (supplier) code instead of setting up an MSF code when it fits the following criteria

• technical complexity of the assortment
• clear codification of maximum 16 characters set up by the manufacturer with a good documentation reference, that can easily be consulted (catalogue or online)
• many articles concerning the same purpose or main article

On logistical side this is the case for articles such as Toyota spare parts.

On medical side this it the case for articles used for internal fixation: Stryker system and Nail of Sign.

These specific codes, called free codes, are built up with an MSF group and family followed by the manufacturer’s code which could be up to 16 characters long.

Example:

CORTICAL SCREW, self tapping, full thread, Ø4.5 x 24 mm (STRY340624);

V-BELT fan and alternator, PZ-HZJ78/79, pair (YTOY90916-02452).

Specialised food products

Unlike basic food products (NFOO family), such as cereals (millet, sorghum...) or legumes (beans...), specialised food products‌ (NFOS family) are specifically designed to meet the needs of malnourished individuals in crisis situation.

These products are enriched with proteins, minerals, and vitamins according to the nutritional requirements of patients, considering factors such as age, severity of malnutrition, associated pathologies, and local dietary habits.

A global strategy for responding to a nutritional crisis can only be developed following an assessment of the nutritional situation, with clear identification of intervention goals and target populations. The response may be general or targeted, and can include general distribution, blanket feeding, supplementary feeding programs, or therapeutic feeding programs.

THE DIFFERENT TYPES OF SPECIALISED FOOD PRODUCTS

Specialised foods are designed to meet specific nutritional needs and can be grouped into several categories:

Therapeutic milks (F75 and F100)

Used in the treatment of Severe Acute Malnutrition (SAM):

• F75: used during the initial phase
• F100: used during the rehabilitation phase

RUTF - Ready-to-Use Therapeutic Food

Used in the rehabilitation phase of Severe Acute Malnutrition (SAM) treatment. Not suitable for the initial phase due to iron content.

• Examples: Plumpy’nut, eeZeepaste, Valid Nutrition, Insta paste, BP100

Caution: RUTF should not be used in children under 6 months of age.

RUSF - Ready-to-Use Supplementary Food

Used in the treatment of Moderate Acute Malnutrition (MAM) and as nutritional support in emergency contexts or to prevent malnutrition in nutritional programs.

• Examples: Plumpy'Sup, eeZeRUSF

Note: RUSF are sometimes referred to as LNS LQ (Large Quantity)

LNS - Lipid-based Nutrient Supplements

LNS MQ (Medium Quantity)

Ready-to-use product used to prevent Moderate Acute Malnutrition (MAM) in children aged 6 to 36 months. When consumed as a supplement to the regular diet, it balances the daily intake of micronutrients.

• Examples: Plumpy doz, eeZee50

LNS SQ (Small Quantity)

Ready-to-use product used to prevent malnutrition and nutritional support in emergencies.

• Examples: Nuttributter, eeZee20

Micronutrients Supplements (fortified paste with vitamins and minerals)

Used to correct dietary deficiencies, especially where diets lack of animal-based products.

• Examples: QBmix

Emergency Food Rations

Compressed biscuits used as nutritional substitutes or food supplements during the early phase of an emergency, before general ration distribution.

• Examples: BP5, NRG5

Infant Formulas (infant milks) and Breast-Milk Fortifiers

Used as breast milk substitutes or to enhance breast milk, when needed for infants with special nutritional requirements.

FSMP - Food for Special Medical Purposes

Tailored for patients with specific medical conditions (e.g., VHF, burns, HIV) and used under medical supervision. Can vary by:

• Age group: adults or children
• Caloric content: isocaloric or hypercaloric
• Protein content: normoprotein or hyperprotein
• Composition: semi-elemental, with or without fibres
• Forms: powder (for reconstitution), ready-to-use drinks, or ready-to-use bags for enteral (tube) nutrition (ready to hang).

Powders typically have a longer shelf-life (24 months), are more cost-effective than ready-to-use products, and simplify stock management and orders (less product references).

Contact your nutrition advisor before ordering FSMPs can serve as a sole food source or meal supplement (e.g., for VHF/Ebola patients unable to follow a normal diet or with severe anorexia).

Super Cereals (Pre-cooked Fortified Flours)

Used in:

• general distributions (WFP)
• family ration distributions
• supplementary and blanket feeding programs

Made from corn flour (CSB+) or wheat flour (WSB+) and soya cooked by extrusion or micronization, fortified with minerals and vitamins.

• Examples: Unimix (MSF-UNICEF-UNHCR), CSB/CSB+ (WFP), WSB (WFP).

Super Cereal plus (+) are newer versions containing milk, better adapted for children's nutritional needs.

• Examples: CSB++

PURCHASE / ACCEPTANCE OF DONATION OF SPECIALISED FOOD PRODUCTS

It is essential to manage stocks of specialised food products by batch and shelf life. A batch is defined as a quantity produced under homogeneous conditions, although its exact definition may vary depending on the supplier's internal organisation.

The quality of the product depends on every stage of the supply chain:

• supply of raw materials, manufacturing, packaging, storage at the supplier's premises
• transport
• storage
• distribution
• cooking (if applicable)
• consumption

Any issue or negligence at any of these stages can compromise the final product's quality. Therefore, strict adherence to recommended procedures at each stage is essential.

All suppliers of specialised food products must undergo a rigorous validation process to ensure that their products meet high-quality standards. Only validated suppliers should be used for purchases.

Local purchases are only permitted from validated suppliers. A list of validated suppliers is available from section pharmacists and nutrition referents.

All donations of specialised food products must be accompanied by a delivery bill (waybill) that specifies all batch numbers and best-before dates. Upon reception, perform a control check and a quality (organoleptic) evaluation for each donation (see procedure below).

Documentation

Each shipment of specialised food products may include various certificates, which can be requested from the field.

These certificates may include: health certificate, certificate of analysis (mandatory for any reception), certificate of origin, conformity certificate, GMO/non-GMO certificate, etc.

SUPPLY AND STOCK MANAGEMENT

Specialised food must be stored at temperatures below 30ºC to prevent quality issues and deterioration.

For detailed guidance, refer to procedure QA-NFOS-SOP2 "Storage and stock management of specialised food".

If storage conditions in the field exceed or have exceeded 30°C, it is recommended to conduct an analysis in a laboratory to assess the integrity of the product, particularly the vitamin content, as vitamins are the most fragile components and to determine a new shelf life. (see the sampling paragraph below).

Procedures for Quality Control

Control at Reception

Complete the "Check list for control upon receipt": NSFSCRECOSE (English), NSFSCRECOSF (French). These forms are also available on request from the section pharmacist or nutrition referent.

A certificate of analysis (one per batch number) must be provided by the supplier for each delivery.

Specific case - Super Cereals:

For Super Cereals, complete the specific checklist: NSFSQCONFFF (French) / NSFSQCONFFE (English).

Sampling (for analyse in laboratory)

When products have been stored at temperatures above 30ºC, samples must be sent to a laboratory to check the level of fortification, especially vitamin content, which can decrease with heat. This analysis may result in an adjustment of the product's shelf life.

If a quality issue is suspected, it may be necessary to send samples to a laboratory. In such cases, contact your section pharmacist or nutrition referent. You may be asked to complete the sampling report form, NSFSSAMPOSF (French) / NSFSSAMPOSE (English).

The central masterdata system, UniData is implemented with some new codification rules.

The diverse code or “Z-code”, created by the OC’s (Operational Centers) and ESC’s (European Supply Centers) disappeared and are replaced by the code structure of a standard article. It will still be possible to make the difference between a standard, a non-standard code and a non-standard local code with another attribute directly linked to the code.

• STD = standard article ( = validated by the 5 OC’s)
• NST = non-standard article ( = not validated by the 5 OC’s but used by one or few operational centres)
• NSL = non-standard local article ( = validated by one or few operational centres and purchased locally due to country constraints)

A DIVERSE CODE (Z-code) was used in the past for the creation of LOCAL codes. It has a similar structure as the standard codes that allow classifying the referred article according to GROUP and FAMILY (as for a standard article), while clearly indicating who created it:

Places of issue for diverse codes:

• KE MSF in Nairobi
• SL MSF in Sierra Leone...

There are no LOCAL CODES in the catalogues, but they may appear in order tools.

The local codes are nowadays integrated in UniData following the same codification rules as the standard and non-standard codes (regular codes). The diverse codes (Z-codes) are progressively disappearing.

EN 13795-1: Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns (2019)

General

Surgical drapes, including the intended use as a sterile field, and surgical gowns are used to minimize the spread of infective agents to and from patients’ operating wounds, thereby helping to prevent postoperative wound infections.

The performance required of coverings for patients, clinical staff and equipment varies with, for example, the type and duration of the procedure, the degree of wetness of the operation field, the degree of mechanical stress on the materials and the susceptibility of the patient to infection.

The use of surgical gowns with resistance to the penetration of liquids can also diminish the risk to the operating staff from infective agents carried in blood or body fluids.

Critical – less critical areas

Performance requirements are specified depending on product area and performance level.

Critical product area: area with a greater probability to be involved in the transfer of infective agents to or from the wound, e.g. front and sleeves of surgical gowns. The other areas are called “less critical product area”. EN 13795 does not include provisions for the size and position of critical and less critical areas. The user has to decide whether these are suitable to meet the anticipated challenges of a certain surgical procedure.

The American standard ANSI/AAMI PB70 provides more specifications: the critical zone of a surgical gown shall, at a minimum, comprise the front area of the gown from chest to knees and the sleeves from the cuff to above the elbow.

For drapes the identification of critical product area is not mentioned in the standards, but in literature it is mentioned: “The critical zone is usually the centre of the drape, around any fenestrations or openings. This area is often reinforced with additional fabric, which may be fluid absorbent”

If the manufacturer does not differentiate product areas, all areas shall meet the requirements for critical product areas. If there is such differentiation, the manufacturer must supply the information to allow identification of these areas by the user.

The manufacturer must provide information on the performance level to the user.

Characteristics to be evaluated and performance requirements for surgical gowns & drapes

• The biocompatibility of the product shall be evaluated and approved for acceptable risk
• Information on the flammability of the product and fire risks must be provided by the manufacturer on request.
• testing according to EN 13795: Summary see table below
• CA = critical product area
• LCA = less critical product area
• IB = Barrier index

Microbial penetration - dry:

• determine the ability of dry fabric to resist penetration of particles carrying micro-organisms.
• Measure: CFU = number of colonies formed after incubation
• Result: only required for the less critical areas: ≤ 300

Microbial penetration – wet

• Determine a fabric’s resistance to penetration of bacteria in liquid while being subjected to mechanical rubbing
• Measure: number of colonies formed after incubation, expressed in barrier index (BI) 6,0 = no penetration (maximum achievable value)
• Result: only required for the critical areas: ≥ 2.8 (standard performance) or ≥ 6.0 (high performance)

Cleanliness microbial / bioburden

• Estimate the bioburden or number of viable micro-organisms on the fabric prior to sterilization.
• Measure: CFU = number of colonies formed / dm²
• Result : ≤ 300 / dm² for all areas, gowns & drapes (based on the experience of manufacturers and what is routinely available)

Particle release

• = release of fiber fragments and other particles during mechanical stress simulating handling and use. Estimate linting of the fabric in a dry state. Particle release is a concern during surgery: foreign body contamination can cause an increased frequency of postoperative complications. An indirect effect is also observed: fibres and particles can deposit on surfaces in the operating room providing a potential vector for microorganisms to be carried into wounds. Particles smaller than 3µm are too small to carry microorganisms and particles larger than 25µm are too large to remain airborne because of gravity.
• Measure: number of particles 3 – 25 µm generated after twisting ad compressing, expressed as log10 of the count value.
• Result: ≤ 4 for all areas, gowns & drapes

Liquid penetration

• = hydrostatic head test: estimate the resistance of fabrics to liquid penetration by water under constantly increasing hydrostatic pressure
• Measure: the head height results are recorded in centimetres of water pressure on the fabric sample.
• Result:
• less critical areas: ≥ 10 cm H₂O
• critical area standard performance: gowns: ≥ 20 cm H₂O, drapes: ≥ 30 cm H₂O
• critical area high performance: ≥ 100 cm H₂O for gowns & drapes

Bursting strength - dry / wet

• Determine the resistance of a fabric to puncture under dry & wet conditions
• Measure: strength at burst, in kPa
• Results: gowns & drapes: ≥ 40 kPa, not required for the less critical area in wet state

Tensile strength - dry / wet

• Determine the ability of a product to withstand fabric tearing under dry and wet conditions
• Measure: amount of force applied to break the strip, in Newton
• Results (not required for the wet less critical areas)
• gowns: ≥ 20 N
• drapes: ≥ 15 N (standard performance) or ≥ 20 N (high performance)

Guidance for selecting products

Comfort is based on several factors: thermal resistance, air permeability, drapeability, stretchability, weight, size, fit, tactile comfort (softness = highly dependent on fibre smoothness and finish technologies), fibres and manufacture. Discomfort properties such as rustling tendency and skin irritation are difficult to measure.

The standard does not provide further essential requirements regarding flammability. However, manufacturers are required to supply information regarding fire risks in relation to the use of their products.

Specific tests for electrostatic discharge (ESD) re not required as no reports were made of patient safety incidents related to ESD.

EN 13795 does not specify requirements for the functional design of surgical gowns & drapes.

The products should be tested practically in clinical situations where the end-user is going to apply them, to ensure that they are suitable from all important aspects including functionality and comfort. The practical trials should be evaluated before choice of products.

The cholera kit 001 is specially designed for refugee camps.

It can also be used for urban or rural populations, altough being less adapted (in this case, small kits for 10 or 50 patients are to be made on the spot according to the needs and the available means).

This kit is meant for the treatment of 625 cholera cases, of which 75 % (500 cases) need IV and ORS, and 25 % (125 cases) need ORS only. These proportions are different from those recommended by the WHO and are based on the MSF experience showing an often high proportion of severely dehydrated cases. In urban or rural areas, only 20 % of the cholera cases need IV and ORS.

The antibiotics supplied cover all cholera cases plus 4 close contacts per case (2 500 contacts). MSF does not recommend chemoprophylaxis of close contacts, but supplies antibiotics for this purpose in case local circumstances demand their use (high secondary attack rate, political pressure, strategic reasons, etc.).

The complete kit (KMEDKCHO1--) is composed of a medical part with 2 infusions modules (2000 l each) and a logistic part. If logistic modules are made locally, it is possible to order medical modules only:

• (KMEDKCHO2M-) with 4000 l infusions
• (KMEDKCHO3M-) with 2000 l infusions
• (KMEDKCHO4M-) without infusions module

These two last kits are proposed because of the transport costs of infusions modules. If quality assured Ringer lactate (Hartmann) has been identified and validated by your section pharmacist or if you have quality assured Ringer lactate in your emergency stock, you can consider ordering the following kits: KMEDKCHO3M- or KMEDKCHO4M-.

NOTE

It is mandatory to have minimum 4000 l of Ringer Lactate (Hartmann) to one's disposal for the IV treatment of 500 cholera patients.

An underestimation of needs which could lead to infusion stocks running out during an epidemic is always more expensive than ordering 4000 l in the first place.

Take 10 samples with the sample module 001 (KMEDMSAM1C-) and send them to headquarters for culture and sensitivity.

Supplies to be got locally if possible

• Ringer lactate (Hartmann), after the medical/public health dpt's approval
• Plastic sheeting (for shelters, insulation...)
• Oral Rehydration Salt (ORS)
• Blankets
• Tent 27 m² (white)
• Calcium Hypochlorite (HTH)
• Watertight boots
• Washing product (soap or powder)
• Minimal medicine cabinet
• Tubes (to make stretchers with plastic sheeting)

See Management of a cholera epidemic, MSF, 2018

Everytime a respirator is put on, PERFORM A SEAL CHECK

Stand in front of a mirror and fully open the respirator

STEP 1: Cup the respirator in your hand with the nosepiece at your fingertips

STEP 2: Position the respirator under your chin with the nosepiece up in order to cover the chin, the mouth and the nose

STEP 3: Pull the top strap over your head resting it high at the back of your head. Pull the bottom strap over your head and position it around the neck below the ears

STEP 4: Mould the nosepiece (using two fingers of each hand), to the shape of your nose

STEP 5: Cover the respirator with both hands, being careful not to disturb the position of the respirator

• Inhale deeply in order to create an air vacuum: if the seal is good, the respirator will cling to your face
• Exhale sharply: if the seal is good, the respirator will slightly expand
• Inhale and exhale several times: no leakage of air between the face and the respirator may be detected

If problems are met (the respirator does not collapse neither expand or if air leak is detected), adjust the respirator and retest the seal. In case the problems persist, replace the respirator and/or try another model or size. Once the respirator is correctly fitted, don't manipulate it any longer.

INTRODUCTION

Cytotoxic drugs are toxic compounds and are known to be carcinogenic, mutagenic and/or teratogenic. On direct contact, they may cause skin, eyes, and mucous membranes irritation, as well as tissue ulceration and necrosis. The toxicity of cytotoxic drugs makes it necessary to minimise the exposure of health-care workers to these drugs. The handling and administration of cytotoxic drugs should not be carried out by pregnant staff. At the same time, aseptic conditions should be maintained.

In order to highlight the danger of cytotoxic materials, the following signs are used:

• In some countries, it is mandatory that cytotoxic drugs and their waste are properly identified with the capital “C” symbol and, under it, the words “CYTOTOXIC /CYTOTOXIQUE “ in capital letters, and the both words and the symbol should appear on a dark grey rectangle.
• This sign will be added to the cytotoxic drugs in the MSF catalogue.

• Cytotoxic materials can also be identified by a purple symbol representing a cell in the late phase of division know as telophase. The labels are dark purple and bear the telophase symbol.

CYTOTOXIC DRUGS IN THE MSF STANDARD LIST (ACCORDING WHO CLASSIFICATION)

http://www.whocc.no/atc_ddd_index/?code=L01D&showdescription=no

GENERAL RULES

• Safety measures: ensure that safety equipment, protocols, and instructions are available in all areas where cytotoxic drugs are stored, handled, prepared, administered and disposed of.
• Minimise handling and movement of cytotoxic drugs from reception to preparation.
• Medicines should remain in their original secondary or tertiary packaging (sealed plastic bag and/or cartons), as the outside of many commercial vials may be contaminated, presenting an exposure risk to anyone handling them.
• Cytotoxic vials are usually well-packaged by pharmaceutical companies, so no specific Personal Protective Equipment (PPE) is required for staff transporting cytotoxic agents, as long as the original packaging is intact and there are no signs of damage or leakage.
• For vials that have not been opened but are no longer in their original packaging, use protective gloves (nitrile, powder-free).
• As damage or leakage can only be detected by handling the product, wearing gloves is advisable when handling cytotoxic agents.
• Centralise the preparation of cytotoxic agents:A
• One single person should transport all cytotoxic drugs needed for the next 24 hours from the pharmacy to preparation area at one time.
• Prepare the drugs in one place.
• Provide safety equipment (see below) in all areas where cytotoxic drugs are stored, handled, prepared or administered.
• Easily visible posters with protocols/instructions describing how to manage cytotoxic drug spills should be available on the wards and are part of nursing care.
• The following materials should be present (or readily available):
• Cytotoxic Spill Kit containing all PPE and materials needed to clean up spills.
• Running water supply + soft soap.
• Device for eye wash (EMEQEYEW7++) (or alternatively 1l of 0.9% NaCl with a 60ml Luer syringe (SINSSYDL60-) or infusion set (SINSSETI2-).
• Movement of cytotoxic drugs should be limited and rationalised. All transports should be coordinated from departure up to the arrival. The TREM card (transport emergency card) and MSDS (material safety data sheet) sheet should be prepared and given to the driver to facilitate transport through customs or by air.

RECEPTION AND STORAGE OF CYTOTOXIC DRUGS

• Ensure that the cytotoxic drugs are stored according to the manufacturer's specific requirements. Be aware that storage conditions may vary between from manufacturers for the same.
• Store cytotoxic drugs centrally in the main pharmacy, avoid storing them in the preparation room.
• Cytotoxic drugs should NOT be stored near or on top of other medicines or medical equipment. They must be stored securely to minimise the risk of breakage and contain any spillage. Ensure clear, visible labelling for easy identification.
• The best storage option is a closed cupboard. Lower shelves mat be used as an alternative, but the storage area should limit the risk of contamination or exposure.
• Labelling and storage directions:
• Mark boxes with arrows on the outside to indicate the box proper storage orientation (to prevent the box from being turned upside down).
• Apply a "hazardous" sticker to the box.
• Ensure that all labels are clear and understandable for all staff involved in handling of the cytotoxic products.
• Reception: visually inspect cytotoxic drugs upon receipt to check for any damage or leakage during transport. In damage or leakage is detected, appropriate PPE should be worn, and proper actions must be taken immediately.

CYTOTOXIC SPILL KIT

A Cytotoxic Spill Kit must be available in all areas where cytotoxic substances are used. All staff handling cytotoxic drugs and waste should be trained in spill management and decontamination. A ready-to-use cytotoxic spill kit can be ordered (SDDCCYTTS2-).

• PPE
• 1 surgical cap (ELINCADS1S-)
• 1 pair of shoe covers (ELINSHOC001)
• 4 pairs of of long-sleeved nitrile examination gloves (SMSUGLEN1+++): inner and outer pair, for 2 persons
• 2 respirators FFP2 (ELINMASP+++)
• 2 protective glasses (SPPEGOGPR++)
• 1 non-woven surgical gown (ELINGOWS+++)
• Pean forceps (ESURFOAP14S) or standard dressing forceps (ESURFODR14-) for collecting glass from broken ampoules or vials.
• Single-use plastic sharps container (SINSCONT2P-).
• Disposable absorbent material such as cotton rolls, compresses, toilet paper, or kitchen paper. Enough to absorb up to 1 litre.
• Absorbent towel with a waterproof layer (ELINDRAW6D-)
• Disposable cleaning cloths (towels).
• Liquid soap (for cleaning the floor).
• 3 plastic bags:
• one for contaminated absorbent material and cleaning materials
• one for disposable protective clothing
• one for protective goggles, which should be washed after use.
• 1 biohazardous waste bag (ELABBAGR001) to place the first two bags.
• Instruction card for safely mopping up spills on surfaces.
• Instruction card for wearing / removing PPE.

Remark on gloves

All gloves have some degree of permeability to cytotoxic drugs, and this permeability increases over time. Vinyl and latex surgical gloves should not be used, as they do not provide the required level of protection.

Gloves specifications:

• Gloves should be made from materials that minimise drug permeability, such as nitrile, polyurethane, or neoprene.
• Gloves must be powder-free, as powder can absorb contaminants, increasing the risk of aerosolization and contact contamination
• Gloves should be long enough to cover the gown sleeves when the wearer's arm is fully extended

SPILL MANAGEMENT

A system must be in place to promptly report spills or contamination of staff. The incident report should include the following information:

• type of incident
• actions taken to manage the spill
• actions taken to prevent recurrence

PROCEDURE FOR LARGE SPILLS

• Alert and notify:
• Alert people in the immediate vicinity that a hazardous spill has occurred and direct them to stay clear.
• Request assistance from an additional person to provide materials, read the instruction cards, and handle the waste bag.
• Secure the area:
• Cordon off the spill area and, if possible, close windows and doors to contain the spill.
• Turn off any fans or ventilation system that may spread the spill or aerosolised particles.
• Open the Cytotoxic Spill Kit and display hazard signs around the perimeter of the spill area.
• Don PPE in the following order:
• respiratory protection
• goggles
• cap
• first pair of gloves
• gown
• overshoes
• second pair of gloves
• the assistant should also wear two pairs of gloves, goggles, and respiratory protection
• Contain the spill:
• For a liquid spill: cover the spill with an absorbent waterproof plastic-lined towel.
• For a powder spill: cover the spill with absorbent towels to minimise dust production. Carefully wet the towel with water (without flooding the pill), allowing the powder to dissolve and be absorbed by the towel.
• Collect and dispose of the spill:
• Use the scoop and scraper to gather the absorbed material and any broken glass.
• Discard the collected cleaning materials into the first plastic bag held by the assistant.
• Do NOT handle sharps/glass with your hands. Use forceps or tweezers to carefully dispose of needles and glass into the sharps container.
• Clean the area:
• Wash the area several times with water and detergent, rinsing thoroughly each time with water. Always work from the outside of the spill toward the centre.
• Remove PPE in the following order:
• outer gloves
• overshoes
• gown
• goggles
• cap
• respiratory protection
• inner gloves
• place used disposable items into the secondplastic bag.
• place the protective glasses into the third bag for cleaning.
• The assistant (still wearing PPE) closes the first two plastic bags and places them into the "biohazard" bag.
• The assistant removes his PPE and adds the single-use PPE into the "biohazard" bag.
• Wash hands with soap and water.
• Wash goggles in hot, soapy water while wearing non-sterile gloves, then dry with paper towels (discard paper towels into the "biohazard" bag).
• Place the "biohazard" bag into the appropriate hazardous waste bin.
• Contact the waste or Watsan manager responsible for the transport and disposal of the biohazard bag.
• Ensure the Cytotoxic Spill Kit is replaced and fully stocked for future use.

PROCEDURE FOR SMALL SPILLS:
DROPS OR SPLASHES ON EQUIPMENT, FURNITURE, OR FLOOR

• If not already done, don the appropriate PPE as described above.
• Immediately cover the affected area with absorbent material.
• If the spill involves a powder, gently cover with it an absorbent towel to minimise dust production. Wet the towel to dissolve the powder and allow it to absorbed by the towel.
• Carefully collect the absorbed material, making sure to use forceps to pick up any broken glass.
• Discard the collected waste into the appropriate waste bin (solid container dedicated to cytotoxic waste, such as vials, needles etc.).
• Wash the affected area with water and detergent, then rinse thoroughly several times with water.
• Dry the cleaned area using absorbent towels or cloths.
• Discard the waste into the cytotoxic waste bin.
• Remove and dispose of gloves safely, then replace them with clean ones.

MANAGEMENT OF ACCIDENTAL EXPOSURE TO CYTOTOXIC SUBSTANCES

• Inhalation of drug aerosols, dust, powder, or droplets:
• When opening the vial or handling the drug, inhalation of large quantities is unlikely due to the small vial size. If respiratory symptoms occur, move the victim away from the source into fresh air.
• Skin exposure:
• If splashes, drops, or contaminated surface come into contact with healthy skin or a wound, irritation, allergic reaction, itching, burning, and skin lesions (particularly with vincristine) may occur.
• Remove any contaminated clothing or shoes immediately.
• Flush the affected area with a large volume of water for 10-20 minutes, then wash thoroughly with soap and rinse with running water.
• If the skin is damaged, apply a clean dressing.
• Eye contact:
• Flush the eyes with a large volume of water or normal saline eye drops for at least 15-20 minutes.
• Seek immediate medical attention.
• If gloves are worn, remove them before flushing the eyes, as they may be contaminated.
• If contact lenses are worn, remove them immediately before flushing.
• Ingestion (unlikely via splashes, contaminated food, drink, or hand-to-mouth contact).
• Do not induce vomiting.
• Clothing contamination:
• All contaminated clothing should be removed and discarded in the "biohazard" waste bag if it is to be disposed of.
• For clothing that is not to be discarded, wash separately in hot water, and repeat washing.

See also: Hazardous waste management of health structures within low-income Countries, MSF, 2013, 3rd edition.

Contact your section pharmacist for more details.

Protection is vital to ensure safety and performance in challenging conditions, and understanding NIJ ballistic levels is essential for choosing the most appropriate ballistic levels of protection for your application.

The NIJ provides five armor protection level classifications - IIA, II, IIIA, III and IV. The “A” in some levels refers to the fact that the jacket offers more protection than the previous level, but cannot meet the standard of the next level, so it is usually half a step. Although there is a level 1 armor, it is now obsolete and no longer approved by the NIJ due to its low resistance level.

Soft-body vests are generally level IIIA or below, while hard-body vests and ballistic protective equipment are generally level III or above, including armour plates. Each of the five levels of armor has distinct advantages over different types of ammunition:

• Level IIA: This soft body armor is light and undetectable. The wearer is protected from 9mm and .40 Smith & Wesson bullets.
• Level II: Level II is still easy to conceal and light yet offers greater protection than level IIA. It’s designed to protect the wearer from 9mm and .357 magnum ammunition from short-barrel handguns.
• Level IIIA: Level IIIA is soft for easy flexibility but offers excellent protection against .357 SIG and .44 Magnum ammunition from longer-barrel handguns.
• Level III: This hard body armor uses metal plates or other composite materials to withstand rifle rounds. The NIJ tests this armor to withstand 7.62mm FMJ lead core rifle ammunition.
• Level IV: Level IV is the most powerful body armor available. It’s designed specifically for military applications and can withstand .30cal steel core armor-piercing rifle ammunition.
  NIJ standard levels

Definition

SUTURE

• Surgical suture (commonly called stitches) is a medical device used to hold body tissues together after an injury or surgery. Application generally involves using a needle with an attached length of thread. Sutures are used to repair tissue and facilitate healing
• Single-armed suture: the classic combination consists of a thread and a single needle.
• A double-armed suture consists of a thread with a needle at each end.

LIGATURE

• A strand of material used to identify or differentiate anatomical structures and to clamp blood vessels or ducts.

Characteristics of threads used for sutures

Thread memory is the capacity of the suture thread to return to its former, packaged shape. Thread memory has little effect on the quality of the suture, however it does affect manageability, as threads with memory tend to form knots spontaneously during use.

Tensile strength is defined as the force required to break a suture. The knot tensile strength is usually 30 to 50% less than the linear tensile strength of a suture. The suture material and diameter are key factors where tensile strength is concerned.

The capillarity of a suture describes the ease with which fluids can be wicked along the suture thread. This property is inherent to multifilament sutures as a result of the loose interstices of their fibers.

Surgical suture material can be classified on the basis of the characteristics, absorbability, origin of material and thread structure.

Absorbability

Absorption = resorption = loss of mass.

The rate of absorption of absorbable sutures depends on what they are made of and their thickness. Disappearance of the suture occurs through inflammatory reaction, hydrolysis or enzymatic degradation.

Absorbable sutures may be used to hold wound edges in approximation temporarily, until they have healed sufficiently to withstand normal stress. Some are absorbed rapidly, while others are treated or chemically structured to lengthen absorption time.

Non-absorbable sutures are those which are not digested by body enzymes or hydrolyzed in body tissue. They are made from a variety of non-biodegradable materials and are ultimately encapsulated or walled off by the body’s fibroblasts. When used for skin closure, they must be removed postoperatively.

Origin of material :

• Natural absorbable sutures: CATGUT: thread of animal origin.
• Natural non-absorbable sutures
• Silk fibers, often coated with wax or silicone. Tensile strength decreases as moisture is absorbed and is completely lost within 1 year.
• Cotton or linen fibers, or coated natural fibers where the coating contributes to suture thickness without adding strength.
• Metal wire of monofilament or multifilament construction.
• Synthetic origin: produced from synthetic polymers as polyamide, polyolefines and polyesters.

Number of strands:

Sutures are classified according to the number of strands of which they are comprised

Synthetic absorbable sutures

Absorbable sutures are medical devices class III according to rule 8 (surgically invasive long term use, mainly absorbed)

characteristics

Low tissue reaction.

Absorption occurs by enzymatic process. This process can become altered in patients with a fever, infection or protein deficiency, resulting in an accelerated decline of tensile strength. Furthermore, the absorption process can begin prematurely if the sutures are placed in a moist or fluid filled part of the body, or if the material becomes wet or moist during handling or any other time prior to implantation.

composition

Most of synthetic absorbable sutures are made of absorbable polyesters and contain one or more of the five basic building blocks: Glycolide, L-lactide, p-dioxanone, ε-caprolactone and trimethylene carbonate

Table 1: Synthetic absorbable sutures

PGA and PGLA sutures rapid

Absorption rate is higher for the sutures “Rapid” “Fast” or “Quick”: treating absorbable braided sutures with gamma radiation reduces their resistance. Tensile strength 50% @ 5 days, absorption complete by 42 days (PGA rapid is sometimes indicated as PGAP).

Synthetic non-absorbable sutures

Low tissue reaction, uniform and resistant.

Non absorbable sutures are in general medical devices class IIb according to rule 8 (surgically invasive, long term use)

If the suture is intended to be used in direct contact with the heart or central circulatory or nervous system, the medical device class becomes III)

Table 2: Synthetic non-absorbable sutures

Gauge of suture threads

Two parallel systems are used for measuring the gauge of thread (size of the thread):

• EP (European Pharmacopoeia) measurement: decimal size, representing a tenth of the thread diameter, expressed as a Metric size number (Metric 2 = DEC2 = 0.20 mm diameter). It ranges from 0.1 to 7.
• USP (United States Pharmacopoeia) measurement: ranges from 11/0 to 5 (the more zeros in the number, the finer the thread)

Length of the sutures: there is no standard length for the sutures. Manufacturers offer different lengths for each suture, habits change per country, very thin threads are often shorter.

Other features

Colour

The suture threads are available dyed (violet, green, blue, black, etc.) or undyed. The colour acts as an indicator, which can be particularly useful in certain cases (e.g. vascular surgery) for distinguishing the different anatomical structures. The colour enhances their visibility, even if they are steeped in blood. In contrast, undyed threads have the advantage of being less visible and more discreet, and thus better for use in eye surgery or skin suturing, to avoid a tattoo effect.

Coating

Coating is a surface treatment that can be used for the needle as well as for braided sutures and has the purpose of modifying the surface.

Coating the needles improves precision and penetration. Coating the thread optimizes its passage through the tissue and at the same time makes it less traumatic while still maintaining good knot security. However, this surface coating is thin and friction during manipulation can rub off the protective coating.

Antimicrobial suture

They contain / are coated with an agent to locally inhibit bacterial growth: triclosan or chlorhexidine.

• prevent bacterial adhesion and biofilms formation and avoid long-term systemic antibiotics.
• be biocompatible with medical products
• do not impair healing processes and be well tolerated in wounds with no toxicity or systemic absorption.

Barbed suture

The knotless barbed suture is widely used in both skin and deeper structures. It is a specifically designed monofilament suture (absorbable or non absorbable) with barbs orientated in the opposite direction to the needle. While suturing tissue, these barbs penetrate inside the tissue and lock them into place, eliminating the need for knots to tie the suture. Initial fixation of the suture is with a fixation tab or a loop.

Three types according to the direction of the barbs: bidirectional, unidirectional or spiral

PTFE Pledgets

Reinforcement of a suture: PTFE pledgets are used as a suture buttress

• Protect tissue from thread tension
• Distribute tension evenly across the pledget
• Enable better tightening

Various materials and sizes available, packed separately or preloaded on the suture

Control release needle

To save time, the needle-thread combination has been constructed with a removable needle. After the suture has been placed, the needle can be removed from the suture with a slight pull.

​

The suture needle

In addition to the thread, the needle is an essential component of sutures.

Atraumatic sutures are defined as needle-suture combinations, where the (eyeless) needle is firmly attached (swaged) to the suture in order to reduce tissue trauma.

General characteristics

Most of surgical needles are fabricated from heat treated steel. There is no formal definition on what constitutes a "surgical stainless steel", so product manufacturers and distributors apply the term to refer to any grade of corrosion resistant steel.

The most common "surgical steels" are austenitic 316 stainless and martensitic 440 and 420 stainless steels.

The surgical needle has a basic design composed of three parts

• The point is the sharpest portion and is used to penetrate the tissue. The point runs from the tip to the maximum cross-sectional area of the body.
• The body represents the mid portion of the needle, made of solid steel. It is the strongest and widest portion of the needle and is also referred to as the grasping area.
• The swage is the portion to which the suture material is attached. Instrumentation here will break or weaken the suture. This part permits the suture and needle to act as a single unit to decrease trauma

Shape of the needle

Needle Body

Needles with round bodies pierce and spread the tissues with minimal cutting. They are used in easily penetrated tissues like the peritoneum and abdominal viscera.

Needles with triangular shaped bodies are referred to as “cutting” needles. Each of the three edges is a cutting edge, and they are used to penetrate tough tissues and are ideal for suturing skin.

Needle curvature (longitudinal shape)

In practice, the deeper the layer, the more curved the needle should be.

• 1/4 circle: shallow curvature, used on easily accessible convex surfaces: for ophthalmic and microsurgical procedures
• 3/8 circle: most commonly used needle. The curvature makes it easy to manipulate in large and superficial wounds, however it is impossible to use in deep cavities due to the large arc of manipulation needed.
• 4/8 = ½ circle: to be used in confined locations, but requires more pronation and supination of wrists
• 5/8 circle: ideal for deep, confined holes (nasal cavity), and can be used by rotating the wrist with little to no lateral movement.

Needle Point

• Taper point: needle body is round and tapers smoothly to a point. Penetrates the tissue by separating rather than by cutting.
• Conventional cutting: has a triangular cross section with the apex of the triangle on the inside of the needle curvature. The effective cutting edges are restricted to the front section of the needle and merge into a triangulated body which continues for half the length of the needle.
• Reverse cutting needle: is triangular in cross section, having the apex cutting edge on the outside of the needle curvature. This improves the strength of the needle and particularly increases its resistance to bending.
• Protection point: designed to minimize the risk of needle stick injury. The needle point is sharp enough to penetrate fascia and muscle but not skin.
• Blunt point: designed to suture extremely friable tissue such as liver.
• Tapercut needle: combines the initial penetration of a cutting point with the minimized trauma of a round bodied needle. The cutting is limited to the point of the needle, which then tapers out to merge into a round cross section.
• Side cutting or spatula points: flat on top and bottom with a cutting edge along the front to one side, for eye surgery